Clinical trial NCT04532879: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Rome IV Functional Constipation
Lead sponsor: HyGIeaCare, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess change in bowel movements PRE and POST HygiRelief procedure
timeFrame: 12 months
Secondary outcomes:
measure: Assess colon effluent samples (HygiSample) collected during the HygiRelief procedure
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: