HygiRelief Procedure and HygiSample Evaluation for Functional Constipation

HyGIeaCare, Inc.

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Rome IV Functional Constipation

Interventions

HygiPrep (HyGIeaCare System)DEVICE

Controlled gravity-based high-volume colon irrigation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

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

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.