HygiRelief Procedure and HygiSample Evaluation for Functional Constipation

Not Applicable

Withdrawn

• Conditions: Rome IV Functional Constipation
• Interventions: Device: HygiPrep (HyGIeaCare System)

• Registration Number: NCT04532879
• Lead Sponsor: HyGIeaCare, Inc.

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.

Study Timeline

• Study First Submitted: 2020-08-20
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-31
• Status Verified: 2021-09
• Study Start: 2021-09
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-17
• Primary Completion: 2022-03
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients enrolled	HygiPrep (HyGIeaCare System)	Bowel habits before and after the HygiRelief procedure will be assessed. Samples will be sent for microbiome evaluation.

Primary Outcome Measures

Name	Time	Method
Assess change in bowel movements PRE and POST HygiRelief procedure	12 months	Evaluate the clinical effectiveness of the HygiRelief procedure to relieve functional constipation in patients previously managed with a stable dose of Lizess

Secondary Outcome Measures

Name	Time	Method
Assess colon effluent samples (HygiSample) collected during the HygiRelief procedure	12 months	Samples will be evaluated for their microbiological and biochemical content, as well as to identify microbiome changes throughout the colon