Back to resultsHygiRelief Procedure and HygiSample Evaluation for Functional Constipation
Primary Purpose
Rome IV Functional Constipation
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HygiPrep (HyGIeaCare System)
Sponsored by
About this trial
This is an interventional treatment trial for Rome IV Functional Constipation
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All patients enrolled
Arm Description
Bowel habits before and after the HygiRelief procedure will be assessed. Samples will be sent for microbiome evaluation.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04532879
Brief Title
HygiRelief Procedure and HygiSample Evaluation for Functional Constipation
Official Title
HygiRelief Procedure and HygiSample Evaluation for Patients Diagnosed With Rome IV Functional Constipation Previously Managed With Linzess
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
decided not to do the study due to Covid staffing restrictions
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HyGIeaCare, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rome IV Functional Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All patients enrolled
Arm Type
Experimental
Arm Description
Bowel habits before and after the HygiRelief procedure will be assessed.
Samples will be sent for microbiome evaluation.
Intervention Type
Device
Intervention Name(s)
HygiPrep (HyGIeaCare System)
Other Intervention Name(s)
HygiSample (stool collection for microbiome evaluation)
Intervention Description
Controlled gravity-based high-volume colon irrigation
Primary Outcome Measure Information:
Title
Assess change in bowel movements PRE and POST HygiRelief procedure
Description
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 Outcome Measure Information:
Title
Assess colon effluent samples (HygiSample) collected during the HygiRelief procedure
Description
Samples will be evaluated for their microbiological and biochemical content, as well as to identify microbiome changes throughout the colon
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
HygiRelief Procedure and HygiSample Evaluation for Functional Constipation
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