HygiRelief Procedure and HygiSample Evaluation for Functional Constipation

NCT ID: NCT04532879

Last Updated: 2021-09-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2022-06-30

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

Rome IV Functional Constipation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

All patients enrolled

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

Samples will be sent for microbiome evaluation.

Group Type: EXPERIMENTAL

HygiPrep (HyGIeaCare System)

Intervention Type: DEVICE

Controlled gravity-based high-volume colon irrigation

Interventions

HygiPrep (HyGIeaCare System)

Controlled gravity-based high-volume colon irrigation

Intervention Type: DEVICE

Other Intervention Names

HygiSample (stool collection for microbiome evaluation)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HyGIeaCare, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HGP-0009

Identifier Type: -

Identifier Source: org_study_id