## Protocol Section
### Identification Module
**NCT ID:** NCT04532879

**Brief Title:** HygiRelief Procedure and HygiSample Evaluation for Functional Constipation

**Official Title:** HygiRelief Procedure and HygiSample Evaluation for Patients Diagnosed With Rome IV Functional Constipation Previously Managed With Linzess

#### Organization Study ID Info
**ID:** HGP-0009
#### Organization
**Class:** INDUSTRY
**Full Name:** HyGIeaCare, Inc.
### Status Module
#### Completion Date
**Date:** 2022-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-09-17

**Type:** ACTUAL

**Last Update Submit Date:** 2021-09-10

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2022-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-09

**Type:** ESTIMATED

**Status Verified Date:** 2021-09

#### Study First Post Date
**Date:** 2020-08-31
**Type:** ACTUAL
**Study First Submit Date:** 2020-08-20
**Study First Submit QC Date:** 2020-08-26
**Why Stopped:** decided not to do the study due to Covid staffing restrictions
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** HyGIeaCare, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study has a single center, prospective, open label design. The population will include patients diagnosed with Rome IV Functional Constipation who are at the time of study enrollment being managed with a stable dose of Linzess. They will stop taking their Linzess, undergo monitoring of bowel habits for 2 weeks, have a HygiRelief procedure and then undergo an additional 2 weeks of bowel habit monitoring.

**Detailed Description:** After undergoing a 5-7 day Linzess washout period, patients will record their bowel habits in a daily diary for 2 weeks. Patients will have the HygiRelief procedure with a HygiSample evaluation, then they will record their bowel habits in a daily diary for 2 weeks following the HygiRelief procedure.

HygiSamples (stool samples) will be collected throughout the HygiRelief procedure and the samples will be sent for microbiome evaluation.

Patients will complete multiple questionnaires - Happiness Scale, Hospital Anxiety and Depression Scale (HADS), and a personal assessment which includes the Constipation Symptom Score and Adverse Event Screening. These will be completed at Baseline, after the 2 week PRE-HygiRelief period, and after the 2 week POST-HygiRelief period.

### Conditions Module

**Conditions:**

- Rome IV Functional Constipation

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Prospective, single center, open label. Patients will serve as their own control by comparing their bowel habits using a specific diary 2 weeks after the Linzess washout period to the 2 weeks after their HygiRelief procedure.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Bowel habits before and after the HygiRelief procedure will be assessed.

Samples will be sent for microbiome evaluation.

**Intervention Names:**

- Device: HygiPrep (HyGIeaCare System)

**Label:** All patients enrolled

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- All patients enrolled

**Description:** Controlled gravity-based high-volume colon irrigation

**Name:** HygiPrep (HyGIeaCare System)

**Other Names:**

- HygiSample (stool collection for microbiome evaluation)

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Evaluate the clinical effectiveness of the HygiRelief procedure to relieve functional constipation in patients previously managed with a stable dose of Lizess

**Measure:** Assess change in bowel movements PRE and POST HygiRelief procedure

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** Samples will be evaluated for their microbiological and biochemical content, as well as to identify microbiome changes throughout the colon

**Measure:** Assess colon effluent samples (HygiSample) collected during the HygiRelief procedure

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Patient's age is between 18 and 80 years old
2. Patient diagnosed with Rome IV Functional Constipation (Attachment C2)
3. Patient is currently managed with Linzess and willing to stop taking it for study duration

Exclusion Criteria:

1. Patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation)
2. Patient has any other condition that, in the opinion of the investigator, may adversely affect the compliance or safety of the patient or would limit the patient's ability to complete the study
3. Patient has any of the contraindications listed below:

   1. Cardiac: Congestive heart failure (NYHA class III or IV or EF \<50%)
   2. GI: Intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon, rectal, or abdominal surgery
   3. GU: Renal insufficiency (CC \< 60 ml/min/173m2), cirrhosis with ascites
   4. Abdominal surgery within the last 6 months
   5. Pregnancy
4. Patient took antibiotics within two months of starting the study

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012817

- Term: Signs and Symptoms, Digestive

### 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: HIGH

- As Found: Constipation

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003248

- Term: Constipation

### Intervention Browse Module - Browse Branches

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: HB

- Name: Herbal and Botanical

### Intervention Browse Module - Browse Leaves

- ID: M252449

- Name: Linaclotide

- Relevance: LOW

- As Found: Unknown

- ID: T120

- Name: Cola

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
