## Protocol Section
### Identification Module
**NCT ID:** NCT06419231

**Brief Title:** Effectiveness of a Butyrate Formulation and Butyrate + Polyphenol Formulation on Gut Health, Permeability and Associated Symptoms

**Official Title:** A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of a Butyrate Formulation and a Butyrate + Polyphenol Formulation on Gut Health, Permeability and Associated Symptoms

#### Organization Study ID Info
**ID:** CL115
#### Organization
**Class:** INDUSTRY
**Full Name:** Supplement Formulators, Inc.
### Status Module
#### Completion Date
**Date:** 2025-02-21

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-01-24

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-10-31

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Compound Solutions Inc.

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Supplement Formulators, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is the assess the effectiveness and safety of a Butyrate formulation and a Butyrate + Polyphenol formulation on gut health, permeability and associated symptoms

**Detailed Description:** This is a double-blind, randomized, placebo-controlled, remote design study to evaluate the effects of a Butyrate formulation and Butyrate + Polyphenol formulation on gut health, intestinal permeability and associated symptoms.

Participants will be asked to complete laboratory assessments and questionnaires. A total of up to 105 subjects (35 subjects per arm) will be enrolled in a randomly assigned sequence for the 28-day period. There will be three scheduled remote videoconferencing visits with two scheduled telephone contacts. The study subjects will complete assessment tools that include the Gastrointestinal Symptoms Rating Scale for IBS (GSRS-IBS), Digestion-Associated Quality of Life Questionnaire (DQLQ), Visual Abdominal Scale of Abdominal Pain, Bristol Stool Form (BSFS), Gastrointestinal-Global Assessment of Improvement (Gastrointestinal-GAI) and the Short Form-36 Health Survey (SF-36). Laboratory testing will include Gut Microbiome, Short Chain Fatty Acid Analysis, Gut Barrier Panel and Intestinal Permeability.

### Conditions Module

**Conditions:**

- Gut Health

**Keywords:**

- Gastrointestinal discomfort, abdominal pain, gas, bloating, diarrhea, constipation, heartburn, abdominal discomfort

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 105

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Butyrate Formulation: Take three (3) capsules daily in the morning with 8 oz. (240ml) of water

**Intervention Names:**

- Dietary Supplement: Butyrate Formulation

**Label:** Butyrate Formulation

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Butyrate + Polyphenol Formulation: Take three (3) capsules daily in the morning with 8 oz. (240ml) of water

**Intervention Names:**

- Dietary Supplement: Butyrate + Polyphenol Formulation

**Label:** Butyrate + Polyphenol Formulation

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Placebo: Take three (3) capsules daily in the morning with 8 oz. (240ml) of water

**Intervention Names:**

- Dietary Supplement: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Butyrate Formulation

**Description:** Butyrate Formulation capsule:3 capsules daily

**Name:** Butyrate Formulation

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Butyrate + Polyphenol Formulation

**Description:** Butyrate + Polyphenol Formulation capsule: 3 capsules daily

**Name:** Butyrate + Polyphenol Formulation

**Type:** DIETARY_SUPPLEMENT

#### Intervention 3

**Arm Group Labels:**

- Placebo

**Description:** Placebo: 3 capsules daily

**Name:** Placebo

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** Assessment of the median change in the Gut Microbiome from baseline.

**Measure:** Gut Microbiome

**Time Frame:** 28 days

**Description:** Assessment of the median change in the Gastrointestinal Symptom Rating Scale-IBS from baseline.

**Measure:** Gastrointestinal Symptom Rating Scale- IBS (GSRS-IBS)

**Time Frame:** 28 days

#### Secondary Outcomes

**Description:** Assessment of the median change in the Gut Barrier Panel Finger Stick Test from baseline.

**Measure:** Gut Barrier Panel Finger Stick Test

**Time Frame:** 28 days

**Description:** Assessment of the median change in the Short Chain Fatty Acid Analysis from baseline.

**Measure:** Short Chain Fatty Acid Analysis (SCFA)

**Time Frame:** 28 days

**Description:** Assessment of the median change in the Intestinal Permeability Test from baseline.

**Measure:** Intestinal Permeability Test (IP)

**Time Frame:** 28 days

**Description:** Assessment of the median change in the Digestive Quality of Life Questionnaire from baseline.

**Measure:** Digestive Quality of Life Questionnaire (DQLQ)

**Time Frame:** 28 days

**Description:** Assessment of the median change in the Visual Analogue Scale Questionnaire of abdominal pain from baseline.

**Measure:** Visual Analogue Scale questionnaire of abdominal pain

**Time Frame:** 28 days

**Description:** Assessment of the median change in the Bristol Stool Form from baseline.

**Measure:** Bristol Stool Form (BSFS)

**Time Frame:** 28 days

**Description:** Assessment of the median change in the Gastrointestinal- global assessment of improvement scale from baseline.

**Measure:** Gastrointestinal- global assessment of improvement scales (Gastrointestinal- GAI)

**Time Frame:** 28 days

**Description:** Assessment of the median change in the SF-36 Health Survey from baseline

**Measure:** Short Form-36 Health Survey (SF-36 Health Survey)

**Time Frame:** 28 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Ambulatory, male or female, 21-70 years of age
2. A BMI of 18.5-34.9
3. Experiences at least three of the following conditions on a weekly basis (gastrointestinal discomfort, abdominal pain, gas, bloating, diarrhea or constipation)
4. Are comfortable fasting overnight
5. Are able to complete study procedures for up to approximately 6 hours on 2 separate days
6. Considered to be generally healthy on the basis of medical history
7. Willing to follow study instructions, including compliance with the study procedures and requirements

Exclusion Criteria:

1. Unable to provide a urine specimen, stool specimen or blood sample from a finger stick
2. Currently on a galactose/lactose restricted diet
3. Having taken proton pump inhibitors (e.g. omeprazole, pantoprazole) within the past 3 months
4. History of oral antibiotic use within the past 3 months
5. Current or previous history of gastrointestinal disease including gallbladder problems, gallstones, biliary obstruction, irritable bowel disease (IBD) or that may interfere with the outcome parameters
6. Current or previous history of gastrointestinal cancer
7. Currently experience or have had a gastrointestinal infection (virus or bacterial) or food poisoning within the past month
8. Currently experience or have had a parasitic infection within the past 3 months
9. Currently experience or have a history of Crohn's disease, colitis, or celiac disease
10. Currently experience or have a history of severe endometriosis
11. History of gastrointestinal surgery which might influence gastrointestinal function except appendectomy or cholecystectomy
12. .History of thyroid disease (except on a stable dose of medication for ≥ 3 months before screening and unlikely to change medication or dose during the study)
13. History of hypertension (except on a stable dose of medication for ≥ 3 months before screening and unlikely to change medication or dose during the study)
14. A medical or surgical event requiring hospitalization, outpatient visits or emergency room visits within the past 5 years or in the judgment of the Study Investigator /Sub-I would preclude participation in the study
15. Current or previous history of diabetes
16. History of a major change in dietary habits with the past 1 month
17. History of cancer (including skin cancer) within the past 5 years
18. Known intolerance or allergy to sugar alcohols including mannitol, sorbitol, xylitol, lactulose or lactose
19. Women who are lactating, pregnant or planning pregnancy within the next two months
20. Women who are currently taking or have taken estrogen and/or progesterone as a method of birth control \< 3 months prior to screening or anticipates a change for the duration of the study period
21. Having donated blood or received a blood transfusion within 30 days before screening
22. Currently participating in another clinical research study or participated in another clinical research study within 30 days prior to screening

**Healthy Volunteers:** True

**Maximum Age:** 70 Years

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** shirsh@lifeextension.com

**Name:** Steven Hirsh, RPh, DPM

**Phone:** 954-202-7679

**Role:** CONTACT

**Contact 2:**

**Email:** gfernandez@lifeextension.com

**Name:** Giovanna Fernandez, BSN, RN

**Phone:** 954-202-7678

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Fort Lauderdale

**Contacts:**

***Contact 1:***

- **Email:** shirsh@lifeextension.com

- **Name:** Steven Hirsh, RPh,DPM

- **Phone:** 954-202-7679

- **Role:** CONTACT

***Contact 2:***

- **Email:** gfernandez@lifeextension.com

- **Name:** Giovanna Fernandez, BSN, RN

- **Phone:** 954-202-7678

- **Role:** CONTACT

***Contact 3:***

- **Name:** Andrew Swick, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Life Extension Clinical Research, Inc.

**State:** Florida

**Status:** RECRUITING

**Zip:** 33304

#### Overall Officials

**Official 1:**

**Affiliation:** Life Extension

**Name:** Andrew Swick, Ph.D

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

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**PMID:** 30298133

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## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6472

- Name: Constipation

- Relevance: LOW

- As Found: Unknown

- ID: M7159

- Name: Diarrhea

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M18311

- Name: Abdominal Pain

- Relevance: LOW

- As Found: Unknown

- ID: M9444

- Name: Heartburn

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
