## Protocol Section
### Identification Module
**NCT ID:** NCT03058679

**Acronym:** DINE-CD

**Brief Title:** Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease

**Official Title:** Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients With Crohn's Disease

#### Organization Study ID Info
**ID:** 825907
#### Organization
**Class:** OTHER
**Full Name:** University of Pennsylvania
### Status Module
#### Completion Date
**Date:** 2020-03-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-07-21

**Type:** ACTUAL

**Last Update Submit Date:** 2021-06-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-03-01

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2021-07-21

**Type:** ACTUAL

**Results First Submit Date:** 2021-03-26

**Results First Submit QC Date:** 2021-06-30

#### Start Date
**Date:** 2017-09-29

**Type:** ACTUAL

**Status Verified Date:** 2021-06

#### Study First Post Date
**Date:** 2017-02-23
**Type:** ACTUAL
**Study First Submit Date:** 2017-02-16
**Study First Submit QC Date:** 2017-02-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Patient-Centered Outcomes Research Institute

**Class:** OTHER

**Name:** Crohn's and Colitis Foundation

**Class:** OTHER

**Name:** University of North Carolina, Chapel Hill

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Pennsylvania

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This protocol is designed to compare the effectiveness of two dietary interventions for patients with Crohn's disease (CD): the Specific Carbohydrate Diet (SCD) and a Mediterranean style diet (MSD) that has been demonstrated to have numerous other health benefits. The two diets will be compared in terms of their ability to resolve both the symptoms and bowel inflammation that characterize this debilitating disease.

**Detailed Description:** This study tested whether the SCD is superior to a MSD for managing symptoms and reducing inflammatory markers in patients with CD.

The study was designed to include 194 patients with CD who have 1) active symptoms defined by a short Crohn's Disease Activity Index (sCDAI) score \>175. Although the initial plan was to also require that all patients have active inflammation documented by a fecal calprotectin (FCP) concentration \>250mcg/g or high sensitivity C-reactive protein (CRP) \>7 mg/L or ulceration of the small bowel and/or colon consistent with an SES-CD score \>4 as documented in routine clinical practice within 4 weeks of screening, a decision was made early in the recruitment period to enroll all patients with CD with sCDAI\>175 regardless of the results of the tests for inflammatory markers and to perform subgroup analyses of those with and without evidence of inflammation.

Eligible participants were randomly assigned to follow one of the diets in a 1:1 ratio. Participants were provided with 3 meals and 2 snacks each day for a period of 6 weeks. The meals and snacks were prepared by the food vendor, Healthy Chef Creations, and were delivered directly to the participant's home once per week. Participants in both groups were also provided with instructions on how to follow the diets on their own. Participants reported their symptoms through an electronic diary and provided stool samples for FCP measurement and blood for CRP measurement at weeks 0, 6 and 12. The primary and secondary outcomes were assessed at week 6. Following week 6, participants were able to pay out of pocket to purchase food from Healthy Chef Creations and/or could attempt to follow their assigned diet completely on their own. At week 12, in addition to the primary and secondary outcomes assessed again

### Conditions Module

**Conditions:**

- Crohn Disease

**Keywords:**

- diet

- specific carbohydrate diet

- Mediterranean style diet

- randomized controlled trial

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 197

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** For the first six 6 weeks of the trial, participants received a weekly delivery of prepared meals compliant with the SCD (breakfast, lunch, dinner, and two 2 snacks per day). Meals were prepared by Healthy Chef Creations (Orlando, FL) based on menus developed by the food vendor in consultation with study dietitians. Participants assigned to the SCD received a three3-day starter diet as recommended in Breaking the Vicious Cycle. Meals were designed to be heated in an oven or microwave. No other preparation was required.

**Intervention Names:**

- Other: Diet

**Label:** Specific Carbohydrate Diet

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** For the first six 6 weeks of the trial, participants received a weekly delivery of prepared meals compliant with the MD (breakfast, lunch, dinner, and two 2 snacks per day). Meals were prepared by Healthy Chef Creations (Orlando, FL) based on menus developed by the food vendor in consultation with study dietitians. Meals were designed to be heated in an oven or microwave. No other preparation was required.

**Intervention Names:**

- Other: Diet

**Label:** Mediterranean Style Diet

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Mediterranean Style Diet

- Specific Carbohydrate Diet

**Description:** food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks

**Name:** Diet

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Assessed by Short Crohn's Disease Activity Index (sCDAI) - diarrhea, abdominal pain and general well being; sCDAI \<150 in the absence of initiation or increase of any CD medications

**Measure:** Percentage of Participants That Achieved Symptomatic Remission at Week 6

**Time Frame:** 6 weeks

**Description:** reduction of calprotectin to less than 250 μg/g and by greater than 50% from screening among those with screening FC \>250 μg/g

**Measure:** Reduction in Bowel Inflammation Among Those Whose Screening Fecal Calprotectin (FC) Was Greater Than 250μg/g at Baseline and Who Had an FC Results at Both Baseline and Week 6

**Time Frame:** 6 weeks

#### Secondary Outcomes

**Description:** Assessed by the CDAI - CDAI \<150

**Measure:** Percentage of Participants That Reached Clinical Remission at Week 6

**Time Frame:** 6 weeks

**Description:** reduction in high-sensitivity CRP (hsCRP) to \<5 mg/L and \>50% reduction from screening among those with screening hsCRP \>5mg/L

**Measure:** Percentage of Participants With a Reduction in Systemic Inflammation at Week 6

**Time Frame:** 6 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria

1. Age ≥18
2. Documented diagnosis of Crohn's disease
3. sCDAI score \>175
4. Documentation of receipt of a baseline stool sample by the data coordinating center and hsCRP.
5. Access to a computer with internet and the ability to complete daily online surveys
6. Capable of providing consent to participate
7. Able to receive weekly food shipments delivered every Friday for 6 weeks

Exclusion Criteria

1. Pregnancy
2. sCDAI \>400
3. Hospitalized patients
4. Anticipated need for surgery within 6 weeks of randomization
5. Use of the Specific Carbohydrate Diet within 4 weeks of screening
6. Start or change\*\*\* dose of thiopurines (azathioprine and 6-MP), methotrexate, natalizumab, or vedolizumab within 12 weeks prior to screening
7. Start or change\*\*\* dose of anti-tumor necrosis factor (TNF) agents (including infliximab (Remicade), adalimumab (Humira), certolizumab pegol (Cimzia), golimumab (Simponi) or ustekinumab within 8 weeks prior to screening.
8. Start or change in dose of any 5-aminosalicylic acid (5-ASA) medications within 2 weeks of screening.
9. Start or change dose of corticosteroids within 1 week of screening or a dose \>20mg/day prednisone or equivalent\*
10. Use of antibiotics (other than topical formulations) for any reason within 2 weeks prior to screening
11. Known symptomatic intestinal stricture.
12. Presence of an ostomy
13. Baseline stool frequency \>4 bowel movements/day when well
14. BMI \<16
15. BMI ≥40
16. Celiac disease
17. Documented C difficile colitis within four weeks of screening
18. Diabetes Mellitus requiring medication
19. Albumin\<2.0mg/dl, within 4 weeks of screening (if tested as part of routine clinical care)
20. Known allergy to tree nuts or peanuts
21. Other conditions that would be a contraindication to any of the study diets or preclude the participant from completing the study.
22. Currently participating in another clinical trial of a drug to treat Inflammatory Bowel Disease (IBD) or a dietary therapy for any indication.

    * Patients may continue these medications at stable dose for the first six weeks and budesonide may be used at any dose. After the 6th week in the study, patients may taper their steroid dose. The study will provide a recommended taper schedule.

      * Loading/induction doses of biologic type medication will be considered a stable doses. \*\*\*Exception for treatment failures: if a subject is determined to fail on any of the following standard lines of treatment at the treating investigator's discretion, subjects may screen for study intervention based upon the following wash out periods: 4 weeks for thiopurine and methotrexate and 8 weeks for natalizumab, vedolizumab, anti-TNF, or ustekinumab.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tucson

**Country:** United States

**Facility:** University of Arizona

**State:** Arizona

**Zip:** 85724

**Location 2:**

**City:** San Francisco

**Country:** United States

**Facility:** UCSF Colitis and Crohn's Disease Center

**State:** California

**Zip:** 94115

**Location 3:**

**City:** Denver

**Country:** United States

**Facility:** University of Colorado Denver

**State:** Colorado

**Zip:** 80204

**Location 4:**

**City:** Atlanta

**Country:** United States

**Facility:** Emory University

**State:** Georgia

**Zip:** 30322

**Location 5:**

**City:** Atlanta

**Country:** United States

**Facility:** Atlanta Gastroenterology

**State:** Georgia

**Zip:** 30342

**Location 6:**

**City:** Chicago

**Country:** United States

**Facility:** University of Chicago

**State:** Illinois

**Zip:** 60614

**Location 7:**

**City:** Evanston

**Country:** United States

**Facility:** NorthShore University HealthSystem

**State:** Illinois

**Zip:** 60201

**Location 8:**

**City:** Evanston

**Country:** United States

**Facility:** Northwestern University

**State:** Illinois

**Zip:** 60208

**Location 9:**

**City:** Indianapolis

**Country:** United States

**Facility:** Indiana University Health University Hospital

**State:** Indiana

**Zip:** 46202

**Location 10:**

**City:** Louisville

**Country:** United States

**Facility:** The University of Louisville

**State:** Kentucky

**Zip:** 40202

**Location 11:**

**City:** Baltimore

**Country:** United States

**Facility:** University of Maryland Baltimore

**State:** Maryland

**Zip:** 21201

**Location 12:**

**City:** Boston

**Country:** United States

**Facility:** Boston Children's Hospital

**State:** Massachusetts

**Zip:** 02115

**Location 13:**

**City:** Chesterfield

**Country:** United States

**Facility:** Clinical Research Institute of Michigan

**State:** Michigan

**Zip:** 48047

**Location 14:**

**City:** Troy

**Country:** United States

**Facility:** Troy Gastroenterology

**State:** Michigan

**Zip:** 48092

**Location 15:**

**City:** Minneapolis

**Country:** United States

**Facility:** The University of Minnesota

**State:** Minnesota

**Zip:** 55455

**Location 16:**

**City:** Plymouth

**Country:** United States

**Facility:** Minnesota Gastroenterology, P.A

**State:** Minnesota

**Zip:** 55446

**Location 17:**

**City:** Rochester

**Country:** United States

**Facility:** Mayo Clinic - Rochester

**State:** Minnesota

**Zip:** 55905

**Location 18:**

**City:** Lebanon

**Country:** United States

**Facility:** Dartmouth-Hitchcock Medical Center

**State:** New Hampshire

**Zip:** 03756

**Location 19:**

**City:** New York

**Country:** United States

**Facility:** NYU Langone Medical Center

**State:** New York

**Zip:** 10016

**Location 20:**

**City:** New York

**Country:** United States

**Facility:** Weill Cornell - NewYork Presbyterian

**State:** New York

**Zip:** 10021

**Location 21:**

**City:** New York

**Country:** United States

**Facility:** Icahn School of Medicine at Mount Sinai

**State:** New York

**Zip:** 10029

**Location 22:**

**City:** New York

**Country:** United States

**Facility:** Lenox Hill Hospital

**State:** New York

**Zip:** 10075

**Location 23:**

**City:** Chapel Hill

**Country:** United States

**Facility:** The University of North Carolina

**State:** North Carolina

**Zip:** 27599

**Location 24:**

**City:** Charlotte

**Country:** United States

**Facility:** Atrium Health (formerly Carolinas HealthCare System)

**State:** North Carolina

**Zip:** 28203

**Location 25:**

**City:** Winston-Salem

**Country:** United States

**Facility:** Wake Forest Baptist Medical Center

**State:** North Carolina

**Zip:** 27157

**Location 26:**

**City:** Cincinnati

**Country:** United States

**Facility:** University of Cincinnati

**State:** Ohio

**Zip:** 45267

**Location 27:**

**City:** Cleveland

**Country:** United States

**Facility:** University Hospitals Cleveland Medical Center

**State:** Ohio

**Zip:** 44106

**Location 28:**

**City:** Columbus

**Country:** United States

**Facility:** Ohio State University - Wexner Medical Center

**State:** Ohio

**Zip:** 43210

**Location 29:**

**City:** Philadelphia

**Country:** United States

**Facility:** University of Pennsylvania

**State:** Pennsylvania

**Zip:** 19104

**Location 30:**

**City:** Pittsburgh

**Country:** United States

**Facility:** University of Pittsburgh Medical Center

**State:** Pennsylvania

**Zip:** 15213

**Location 31:**

**City:** Providence

**Country:** United States

**Facility:** Lifespan Health System

**State:** Rhode Island

**Zip:** 02903

**Location 32:**

**City:** Nashville

**Country:** United States

**Facility:** Vanderbilt University Medical Center

**State:** Tennessee

**Zip:** 37232

**Location 33:**

**City:** Salt Lake City

**Country:** United States

**Facility:** University of Utah

**State:** Utah

**Zip:** 84112

**Location 34:**

**City:** Seattle

**Country:** United States

**Facility:** Virginia Mason Medical Center

**State:** Washington

**Zip:** 98101

**Location 35:**

**City:** Madison

**Country:** United States

**Facility:** University of Wisconsin-Madison

**State:** Wisconsin

**Zip:** 53706

#### Overall Officials

**Official 1:**

**Affiliation:** University of Pennsylvania

**Name:** James D Lewis, MD, MSCE

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Lewis JD, Sandler RS, Brotherton C, Brensinger C, Li H, Kappelman MD, Daniel SG, Bittinger K, Albenberg L, Valentine JF, Hanson JS, Suskind DL, Meyer A, Compher CW, Bewtra M, Saxena A, Dobes A, Cohen BL, Flynn AD, Fischer M, Saha S, Swaminath A, Yacyshyn B, Scherl E, Horst S, Curtis JR, Braly K, Nessel L, McCauley M, McKeever L, Herfarth H; DINE-CD Study Group. A Randomized Trial Comparing the Specific Carbohydrate Diet to a Mediterranean Diet in Adults With Crohn's Disease. Gastroenterology. 2021 Sep;161(3):837-852.e9. doi: 10.1053/j.gastro.2021.05.047. Epub 2021 May 27. Erratum In: Gastroenterology. 2022 Nov;163(5):1473.

**PMID:** 34052278

## Document Section

### Large Document Module

#### Large Docs

- Date: 2019-04-10

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 1727953

- Type Abbrev: Prot_SAP

- Upload Date: 2020-12-23T10:06

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000015212

- Term: Inflammatory Bowel Diseases

- ID: D000005759

- Term: Gastroenteritis

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000007410

- Term: Intestinal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6638

- Name: Crohn Disease

- Relevance: HIGH

- As Found: Crohn's Disease

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17917

- Name: Inflammatory Bowel Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8875

- Name: Gastroenteritis

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003424

- Term: Crohn Disease

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).

#### Event Groups

**Group ID:** EG000

**Title:** Mediterranean Style Diet

**Deaths Num At Risk:** 92

**Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks

**ID:** EG000

**Other Num Affected:** 18

**Other Num at Risk:** 92

**Serious Number Affected:** 5

**Serious Number At Risk:** 92

**Title:** Mediterranean Style Diet

**Group ID:** EG001

**Title:** Specific Carbohydrate Diet

**Deaths Num At Risk:** 99

**Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks

**ID:** EG001

**Other Num Affected:** 19

**Other Num at Risk:** 99

**Serious Number Affected:** 3

**Serious Number At Risk:** 99

**Title:** Specific Carbohydrate Diet

**Frequency Threshold:** 5

#### Other Events

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Diarrhea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Gastrointestingal disorders other - Worsening of Crohn's disease symptons

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

#### Serious Events

**Term:** Small intestinal obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 92

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 99

**Num Events:** 1

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 92

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 99

**Num Events:** 3

**Term:** Worsening of Crohn's disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 92

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 99

**Num Events:** 2

**Term:** Rectal hemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 92

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 99

**Term:** Diarrhea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 92

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 99

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 92

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 99

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 92

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 99

**Time Frame:** AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 92

**Group ID:** BG001

**Value:** 99

**Group ID:** BG002

**Value:** 191

**Units:** Participants

### Group

**ID:** BG000

**Title:** Mediterranean Style Diet

**Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks

### Group

**ID:** BG001

**Title:** Specific Carbohydrate Diet

**Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 29.5

**Upper Limit:** 53.0

**Value:** 37.0

#### Measurement

**Group ID:** BG001

**Lower Limit:** 27.0

**Upper Limit:** 46.0

**Value:** 36.0

#### Measurement

**Group ID:** BG002

**Lower Limit:** 28.0

**Upper Limit:** 50.0

**Value:** 37

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 63

#### Measurement

**Group ID:** BG001

**Value:** 58

#### Measurement

**Group ID:** BG002

**Value:** 121

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 29

#### Measurement

**Group ID:** BG001

**Value:** 41

#### Measurement

**Group ID:** BG002

**Value:** 70

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 8

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 88

#### Measurement

**Group ID:** BG001

**Value:** 92

#### Measurement

**Group ID:** BG002

**Value:** 180

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 7

**Category Title:** Black

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** Multiracial

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 4

**Category Title:** Other

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** Unknown

#### Measurement

**Group ID:** BG000

**Value:** 86

#### Measurement

**Group ID:** BG001

**Value:** 88

#### Measurement

**Group ID:** BG002

**Value:** 174

**Category Title:** White

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 21.3

**Upper Limit:** 29.9

**Value:** 25.1

#### Measurement

**Group ID:** BG001

**Lower Limit:** 22.5

**Upper Limit:** 29.0

**Value:** 25.6

#### Measurement

**Group ID:** BG002

**Lower Limit:** 21.8

**Upper Limit:** 29.5

**Value:** 25.3

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 68

#### Measurement

**Group ID:** BG001

**Value:** 79

#### Measurement

**Group ID:** BG002

**Value:** 147

**Category Title:** Never

#### Measurement

**Group ID:** BG000

**Value:** 21

#### Measurement

**Group ID:** BG001

**Value:** 20

#### Measurement

**Group ID:** BG002

**Value:** 41

**Category Title:** Past

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** Current

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 5

**Upper Limit:** 21

**Value:** 10

#### Measurement

**Group ID:** BG001

**Lower Limit:** 3

**Upper Limit:** 16

**Value:** 10

#### Measurement

**Group ID:** BG002

**Lower Limit:** 4

**Upper Limit:** 17

**Value:** 10

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 56

#### Measurement

**Group ID:** BG001

**Value:** 60

#### Measurement

**Group ID:** BG002

**Value:** 116

**Category Title:** Non-stricturing, nonpenetrating

#### Measurement

**Group ID:** BG000

**Value:** 19

#### Measurement

**Group ID:** BG001

**Value:** 17

#### Measurement

**Group ID:** BG002

**Value:** 36

**Category Title:** Stricturing

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 13

#### Measurement

**Group ID:** BG002

**Value:** 22

**Category Title:** Penetrating

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 9

#### Measurement

**Group ID:** BG002

**Value:** 17

**Category Title:** Stricturing and penetrating

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 22

#### Measurement

**Group ID:** BG001

**Value:** 30

#### Measurement

**Group ID:** BG002

**Value:** 52

**Category Title:** Ileum alone

#### Measurement

**Group ID:** BG000

**Value:** 17

#### Measurement

**Group ID:** BG001

**Value:** 13

#### Measurement

**Group ID:** BG002

**Value:** 30

**Category Title:** Colon alone

#### Measurement

**Group ID:** BG000

**Value:** 53

#### Measurement

**Group ID:** BG001

**Value:** 55

#### Measurement

**Group ID:** BG002

**Value:** 108

**Category Title:** Ileum and Colon

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Missing

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 24

#### Measurement

**Group ID:** BG001

**Value:** 20

#### Measurement

**Group ID:** BG002

**Value:** 44

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 34

#### Measurement

**Group ID:** BG001

**Value:** 29

#### Measurement

**Group ID:** BG002

**Value:** 63

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 55

#### Measurement

**Group ID:** BG001

**Value:** 53

#### Measurement

**Group ID:** BG002

**Value:** 108

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 11

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 22

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 15

#### Measurement

**Group ID:** BG002

**Value:** 21

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 3

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 14

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 3

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 28

#### Measurement

**Group ID:** BG001

**Value:** 34

#### Measurement

**Group ID:** BG002

**Value:** 62

**Category Title:** 0

#### Measurement

**Group ID:** BG000

**Value:** 22

#### Measurement

**Group ID:** BG001

**Value:** 29

#### Measurement

**Group ID:** BG002

**Value:** 51

**Category Title:** 1

#### Measurement

**Group ID:** BG000

**Value:** 32

#### Measurement

**Group ID:** BG001

**Value:** 26

#### Measurement

**Group ID:** BG002

**Value:** 58

**Category Title:** 2

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 9

#### Measurement

**Group ID:** BG002

**Value:** 18

**Category Title:** 3

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** 4

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 22

#### Measurement

**Group ID:** BG001

**Value:** 23

#### Measurement

**Group ID:** BG002

**Value:** 45

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 27

#### Measurement

**Group ID:** BG001

**Value:** 22

#### Measurement

**Group ID:** BG002

**Value:** 49

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 1.2

**Upper Limit:** 6.2

**Value:** 2.5

#### Measurement

**Group ID:** BG001

**Lower Limit:** 1.4

**Upper Limit:** 8.1

**Value:** 3.2

#### Measurement

**Group ID:** BG002

**Lower Limit:** 1.4

**Upper Limit:** 7.5

**Value:** 2.9

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 28

#### Measurement

**Group ID:** BG001

**Value:** 37

#### Measurement

**Group ID:** BG002

**Value:** 65

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 16.0

**Upper Limit:** 185.0

**Value:** 40.0

#### Measurement

**Group ID:** BG001

**Lower Limit:** 16.0

**Upper Limit:** 223.0

**Value:** 107.5

#### Measurement

**Group ID:** BG002

**Lower Limit:** 16.0

**Upper Limit:** 194.0

**Value:** 70

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 13

#### Measurement

**Group ID:** BG001

**Value:** 23

#### Measurement

**Group ID:** BG002

**Value:** 36

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 80

#### Measurement

**Group ID:** BG001

**Value:** 89

#### Measurement

**Group ID:** BG002

**Value:** 169

**Category Title:** Not performed

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 8

#### Measurement

**Group ID:** BG002

**Value:** 16

**Category Title:** Yes

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Probably

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** Probably not

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** No

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 38

#### Measurement

**Group ID:** BG001

**Value:** 50

#### Measurement

**Group ID:** BG002

**Value:** 88

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 195.7

**Upper Limit:** 247.0

**Value:** 217.7

#### Measurement

**Group ID:** BG001

**Lower Limit:** 197.0

**Upper Limit:** 263.8

**Value:** 226.0

#### Measurement

**Group ID:** BG002

**Lower Limit:** 195.7

**Upper Limit:** 259.6

**Value:** 223.0

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 179.3

**Upper Limit:** 247.0

**Value:** 206.8

#### Measurement

**Group ID:** BG001

**Lower Limit:** 169.8

**Upper Limit:** 246.2

**Value:** 210.0

#### Measurement

**Group ID:** BG002

**Lower Limit:** 171.5

**Upper Limit:** 246.2

**Value:** 209.5

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 33.0

**Upper Limit:** 44.0

**Value:** 38.0

#### Measurement

**Group ID:** BG001

**Lower Limit:** 33.0

**Upper Limit:** 45.0

**Value:** 40.0

#### Measurement

**Group ID:** BG002

**Lower Limit:** 33.0

**Upper Limit:** 45.0

**Value:** 39.0

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 55.9

**Upper Limit:** 65.9

**Value:** 60.4

#### Measurement

**Group ID:** BG001

**Lower Limit:** 54.8

**Upper Limit:** 65.6

**Value:** 58.9

#### Measurement

**Group ID:** BG002

**Lower Limit:** 55.0

**Upper Limit:** 65.8

**Value:** 59.6

**Class Title:** Fatigue

#### Measurement

**Group ID:** BG000

**Lower Limit:** 55.7

**Upper Limit:** 63.8

**Value:** 60.1

#### Measurement

**Group ID:** BG001

**Lower Limit:** 55.7

**Upper Limit:** 63.6

**Value:** 61.3

#### Measurement

**Group ID:** BG002

**Lower Limit:** 55.7

**Upper Limit:** 63.7

**Value:** 61.2

**Class Title:** Pain interference

#### Measurement

**Group ID:** BG000

**Lower Limit:** 51.4

**Upper Limit:** 62.1

**Value:** 57.3

#### Measurement

**Group ID:** BG001

**Lower Limit:** 49.4

**Upper Limit:** 60.2

**Value:** 54.5

#### Measurement

**Group ID:** BG002

**Lower Limit:** 50.9

**Upper Limit:** 61.4

**Value:** 56.0

**Class Title:** Sleep disturbance

#### Measurement

**Group ID:** BG000

**Lower Limit:** 41.0

**Upper Limit:** 56.1

**Value:** 48.4

#### Measurement

**Group ID:** BG001

**Lower Limit:** 34.8

**Upper Limit:** 53.8

**Value:** 47.2

#### Measurement

**Group ID:** BG002

**Lower Limit:** 34.8

**Upper Limit:** 54.5

**Value:** 47.9

**Class Title:** Social isolation

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 30

#### Measurement

**Group ID:** BG001

**Value:** 40

#### Measurement

**Group ID:** BG002

**Value:** 70

**Category Title:** 0

#### Measurement

**Group ID:** BG000

**Value:** 39

#### Measurement

**Group ID:** BG001

**Value:** 40

#### Measurement

**Group ID:** BG002

**Value:** 79

**Category Title:** 1-3

#### Measurement

**Group ID:** BG000

**Value:** 22

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 40

**Category Title:** >3

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** Missing

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 1.0

**Upper Limit:** 4.0

**Value:** 3.0

#### Measurement

**Group ID:** BG001

**Lower Limit:** 1.0

**Upper Limit:** 3.0

**Value:** 2.0

#### Measurement

**Group ID:** BG002

**Lower Limit:** 2.0

**Upper Limit:** 4.0

**Value:** 3.0

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
### Measure 5
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Body Mass Index (BMI)
**Unit of Measure:** kg/m2
### Measure 6
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Smoking status
**Unit of Measure:** Participants
### Measure 7
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Years since CD diagnosis
**Unit of Measure:** years
### Measure 8
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** CD behavior
**Unit of Measure:** Participants
### Measure 9
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Crohn's disease distribution
**Unit of Measure:** Participants
### Measure 10
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** History of perianal fistula
**Unit of Measure:** Participants
### Measure 11
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** History of intestinal surgery
**Unit of Measure:** Participants
### Measure 12
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Current use of any biologic
**Unit of Measure:** Participants
### Measure 13
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Current use of immunomodulators
**Unit of Measure:** Participants
### Measure 14
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Current use of oral 5-ASA
**Unit of Measure:** Participants
### Measure 15
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Current use of rectal 5 ASA
**Unit of Measure:** Participants
### Measure 16
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Current use of oral steroids
**Unit of Measure:** Participants
### Measure 17
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Current use of rectal steroids
**Unit of Measure:** Participants
### Measure 18
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Number of prior anti-TNF medications
**Unit of Measure:** Participants
### Measure 19
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Prior ustekinumab
**Unit of Measure:** Participants
### Measure 20
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Prior vedolizumab
**Unit of Measure:** Participants
### Measure 21
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** hsCRP mg/L
**Unit of Measure:** mg/L
### Measure 22
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** hsCRP >5 mg/L
**Unit of Measure:** Participants
### Measure 23
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** fecal calprotectin (FC) ug/g
**Unit of Measure:** ug/g
### Measure 24
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** fecal calprotectin (FC) >250 ug/g
**Unit of Measure:** Participants
### Measure 25
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Inflammation on colonoscopy
**Unit of Measure:** Participants
### Measure 26
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** FC>250 ug/g or hsCRP>5 mg/L or definite inflammation on colonoscopy
**Unit of Measure:** Participants
### Measure 27
**Description:** Short Crohn's Disease Activity Index. This is a method to measure Crohn's disease patient's symptoms using only a questionnaire,which can be completed without an office visit or lab work. The variables included in the short CDAI are abdominal pain, diarrhea frequency, and general well-being. The higher the score, the worse the disease activity. The sCDAI uses the same scale as the full CDAI, such that scores,\<150 define remission, 150 to 219 mild activity, 220 to450 moderate activity, and.450 severe activity. The total score is reported.
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** sCDAI (median, Q1-Q3)
**Unit of Measure:** units on a scale
### Measure 28
**Description:** The Crohn's Disease Activity Index - CDAI scores range from 0 to 600. A score of less than 150 denotes relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease. The higher the score, the worse the disease activity.

This index uses the following variables to determine a score: number of stools, abdominal pain, general well-being, extraintestinal complications, antidiarrheal agents used in the previous 7 days, abdominal mass felt on palpation, hematocrit, and body weight
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** CDAI (median, Q1-Q3)
**Unit of Measure:** units on a scale
### Measure 29
**Description:** The SIBDQ is a 10-item health-related quality of life (HRQOL) questionnaire validated for use in CD patients. It assesses physical, social, and emotional status and is scored on a 7-point Likert scale from 1 (severe problem) to 7 (no problems at all). Scores for each question are summed to provide a total score. The total score is reported. The absolute score ranges from 10 (poor HRQOL) to 70 (optimum HRQOL).
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Short IBDQ (median, Q1-Q3)
**Unit of Measure:** units on a scale
### Measure 30
**Description:** Patient-Reported Outcomes Measurement Information System (PROMIS)- set of person-centered measures that evaluate and monitor health status. All assessments are for the last 7 days. To calculate a total raw score, each item is scored on a scale of 1-5. If the form has 7 items, the lowest possible raw score is 7 and the highest possible raw score is 35. Raw scores are then translated into T scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. T-scores are reported. Higher T-scores denote worse outcomes.
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** PROMIS measures (median, Q1-Q3)
**Unit of Measure:** units on a scale
### Measure 31
**Description:** This self-reported survey assessed five criteria defining possible inflammatory back pain:(1) improvement with exercise (2) pain at night (3) insidious onset (4) age at onset \<40 years and (5) no improvement with rest. The higher the score the more likely the person had inflammatory back pain.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Inflammatory back pain screen
**Unit of Measure:** Participants
### Measure 32
**Description:** Alternate Mediterranean Diet Score - Participants completed a 24-hour dietary recall at baseline, during week 6 and during week 12. These data were used to compute the Alternate Mediterranean Diet Score (AMeD) where a higher score implies greater consistency with a Mediterranean diet. AMeD scores range from 0 (minimal adherence) to 9 (maximal adherence).
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** AMeD Score
**Unit of Measure:** units on a scale
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** lewisjd@pennmedicine.upenn.edu
**Organization:** University of Pennsylvania
**Phone:** 215-573-5137
**Title:** Dr. James D. Lewis
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 40
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 46
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 48
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Assessed by Short Crohn's Disease Activity Index (sCDAI) - diarrhea, abdominal pain and general well being; sCDAI \<150 in the absence of initiation or increase of any CD medications
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** percentage of participants who achieved symptomatic remission at week 6
**Reporting Status:** POSTED
**Time Frame:** 6 weeks
**Title:** Percentage of Participants That Achieved Symptomatic Remission at Week 6
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
**ID:** OG000
**Title:** Mediterranean Style Diet
##### Group
**Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
**ID:** OG001
**Title:** Specific Carbohydrate Diet
#### Outcome Measure 2
**Description:** reduction of calprotectin to less than 250 μg/g and by greater than 50% from screening among those with screening FC \>250 μg/g
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** This measure includes only those whose screening fecal calprotectin (FC) was greater than 250μg/g at baseline and who had an FC results at both baseline and week 6
**Reporting Status:** POSTED
**Time Frame:** 6 weeks
**Title:** Reduction in Bowel Inflammation Among Those Whose Screening Fecal Calprotectin (FC) Was Greater Than 250μg/g at Baseline and Who Had an FC Results at Both Baseline and Week 6
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
**ID:** OG000
**Title:** Mediterranean Style Diet
##### Group
**Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
**ID:** OG001
**Title:** Specific Carbohydrate Diet
#### Outcome Measure 3
**Description:** Assessed by the CDAI - CDAI \<150
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** 6 weeks
**Title:** Percentage of Participants That Reached Clinical Remission at Week 6
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
**ID:** OG000
**Title:** Mediterranean Style Diet
##### Group
**Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
**ID:** OG001
**Title:** Specific Carbohydrate Diet
#### Outcome Measure 4
**Description:** reduction in high-sensitivity CRP (hsCRP) to \<5 mg/L and \>50% reduction from screening among those with screening hsCRP \>5mg/L
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** This measure includes only those that had a screening hsCRP \> 5mg/L and had hsCRP measured at both screening and at week 6
**Reporting Status:** POSTED
**Time Frame:** 6 weeks
**Title:** Percentage of Participants With a Reduction in Systemic Inflammation at Week 6
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
**ID:** OG000
**Title:** Mediterranean Style Diet
##### Group
**Description:** Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
**ID:** OG001
**Title:** Specific Carbohydrate Diet
### Participant Flow Module
#### Group
**Description:** Diet: food for the diet will be provided to the participants for 6 weeks
**ID:** FG000
**Title:** Specific Carbohydrate Diet
#### Group
**Description:** Diet: food for the diet will be provided to the participants for 6 weeks
**ID:** FG001
**Title:** Mediterranean Style Diet
#### Period
**Title:** Baseline to Week 6
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Change in Crohn's disease medication
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 6
###### Reason
**Group ID:** FG001
**Number of Subjects:** 6
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
##### Withdraw
**Type:** Difficulty following the diet
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 99
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 92
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 81
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 77
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 18
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 15
#### Period
**Title:** Week 6 to Week 12
##### Withdraw
**Type:** Change in medication
###### Reason
**Group ID:** FG000
**Number of Subjects:** 5
###### Reason
**Group ID:** FG001
**Number of Subjects:** 7
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 9
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
##### Withdraw
**Type:** Difficulty following the assigned diet
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 81
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 77
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 61
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 60
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 17
**Pre-Assignment Details:** There were 3 main reasons that participants who consented to the study were not randomized. The majority did not meet eligibility criteria. A small number withdrew or were lost to follow-up
**Recruitment Details:** The study was conducted in 33 clinical sites across the United States. Enrollment in the trial occurred between September 29, 2017 and October 8, 2019.
**Has Results:** True