HygiRelief Procedure and HygiSample Evaluation for Functional Constipation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rome IV Functional Constipation

Intervention / Treatment
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* Device: HygiPrep (HyGIeaCare System)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient's age is between 18 and 80 years old Patient diagnosed with Rome IV Functional Constipation (Attachment C2) Patient is currently managed with Linzess and willing to stop taking it for study duration Exclusion Criteria: Patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation) 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 Patient has any of the contraindications listed below: Cardiac: Congestive heart failure (NYHA class III or IV or EF <50%) GI: Intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon, rectal, or abdominal surgery GU: Renal insufficiency (CC < 60 ml/min/173m2), cirrhosis with ascites Abdominal surgery within the last 6 months Pregnancy Patient took antibiotics within two months of starting the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All patients enrolled<br>Bowel habits before and after the HygiRelief procedure will be assessed. Samples will be sent for microbiome evaluation. | Device: HygiPrep (HyGIeaCare System)<br>* Controlled gravity-based high-volume colon irrigation<br>* Other names: HygiSample (stool collection for microbiome evaluation);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess change in bowel movements PRE and POST HygiRelief procedure | Evaluate the clinical effectiveness of the HygiRelief procedure to relieve functional constipation in patients previously managed with a stable dose of Lizess | 12 months | 

Secondary Outcome Measures

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