HygiRelief Procedure and HygiSample Evaluation for Functional Constipation

Rome IV Functional Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04532879
• Other study ID #: HGP-0009
• Status: Withdrawn
• Phase: N/A
• Start date: September 2021
• Est. completion date: June 2022

Study information

• Verified date: September 2021
• Source: HyGIeaCare, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Rome IV Functional Constipation

Intervention

Device:
• HygiPrep (HyGIeaCare System)
Controlled gravity-based high-volume colon irrigation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HyGIeaCare, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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