NCT07756359
Tirzepatide for Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)
Not Yet Recruiting · Phase 4 · University of North Carolina, Chapel Hill · registry updated 2026-08-10
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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.
- Among patients with inflammatory conditions of the pouch, high bowel frequency must be demonstrated despite adequate therapy for intermittent pouchitis, chronic pouchitis, or Crohn's like disease of the pouch. Adequate therapy is required to ensure significant pouch inflammation is not a driver of high bowel frequency (described in
Exclusion
- Exclusion Criteria).
- 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
- Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2