Tirzepatide for Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of North Carolina, Chapel Hill
About this trial
The goal of this clinical trial is to learn if Tirzepatide (Zepbound) can decrease bowel frequency in patients that have an ileal-pouch anal anastomosis (IPAA or pouch) better than standard of care anti-diarrheal therapy.
The main question it aims to answer is:
Does Tirzepatide reduce bowel frequency better than standard of care anti-diarrheal therapy in patients that have a pouch
Participants will:
Visit the clinic 5 times, answer questions about symptoms daily, be assigned to take the study product as instructed and provide a stool sample 4 times.
Eligibility criteria
Qualifiers
Informed consent will be obtained before any study-related procedures
Age > 18 and <80 years
Patients with an IPAA and bowel frequency > 8 bowel movements in 24 hours on at least 4 of 7 days/week (and/or an average of >8 bowel movements in the 7 days preceding enrollment)
Patients must have demonstrated high bowel frequency despite adequate therapy for high bowel frequency with loperamide 2 mg orally every 6 hours as needed (at least 3 doses daily) and/or diphenoxylate/atropine 2 mg orally every 6 hours as needed (at least 3 doses daily) or proven intolerance to these anti-diarrheal medications.
Disqualifiers
Participants with a proven history of ulcerative colitis and history of 1,2, modified -2 or 3 stage IPAA and ileostomy takedown
Ability to access internet for electronic database entry
Prior exposure to tirzepatide or other GLP-1RA
BMI <20 at the time of study screening
Trial design
Treatments tested in this trial
- Tirzepatide
- Loperamide
- Diphenoxylate/Atropine
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of North Carolina, Chapel Hill
Lead sponsor
Eli Lilly and Company
Collaborator
Source ClinicalTrials.gov