Pouch, Ileal, Pouches, Ileoanal, Bowel Diseases, Inflammatory
Conditions
Keywords
High Bowel Frequency, IPAA, ileal pouch-anal anastomosis
Brief summary
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.
Interventions
DRUGTirzepatide
Tirzepatide will be administered subcutaneously
DRUGLoperamide
2 mg orally every 6 hours as needed
2 mg orally every 6 hours
Sponsors
University of North Carolina, Chapel Hill
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients achieving a decrease of the average daily bowel frequency by 30% at week 12 (Week 16 if applicable) | Week 12 (Week 16 if applicable) | Daily bowel frequency will be calculated by the median 24 hour bowel frequency over the 7 days prior to the week 12 assessment; to be eligible for this calculation, participants will need to complete stool diaries on at least 4 of the 7 days. Note: A 30% reduction will equate to 3-4 bowel movements in a 24-hour time period for the anticipated eligible population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients achieving an average bowel frequency of ≤8 bowel movements daily. | Week 1, Week 4, Week 8, Week 12, Week 16 (if applicable) | Daily bowel frequency will be calculated by the median 24 hour bowel frequency over the 7 days prior to the assessment; to be eligible for this calculation, participants will need to complete stool diaries on at least 4 of the 7 days. |
| Change in Cleveland Clinic Global Quality of Life (QoL) scale | Week 1, Week 4, Week 8, Week 12 (Week 16 if applicable) | The Cleveland Clinic Global Quality of Life scale asks the patient to rate their current QoL, current quality of health, and current energy level using a 1-10 rating (where 10 is best). The score on each of these 3 components is added and the final Cleveland Clinic Global Quality of Life utility score can be obtained by dividing this result by 30. A higher score means improved quality of life. |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) incontinence measure | Week 1, Week 4, Week 8, Week 12 (Week 16 if applicable) | The PROMIS measure for incontinence includes 4 items that assess the frequency of bowel incontinence, soiling, stool leakage, and stool leakage while passing gas over the past 7 days. Score range is 0-20, where a higher score means increased incontinence. |
| Number of Participants with AEs, SAEs and AEs Leading to Discontinuation of Study Intervention | Up to Week 12 (Week 16 if applicable) | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, results in another serious or important medical event |
| Number of Participants with worsening laboratory values | Up to Week 12 (Week 16 if applicable) | Number of participants with worsening fecal calprotectin laboratory values will be reported. |
| Number of Participants with changes in nausea | Up to Week 12 (Week 16 if applicable) | Number of participants with self described changes in nausea will be reported |
| Number of Participants with changes in appetite | Up to Week 12 (Week 16 if applicable) | Number of participants with self described changes in appetite will be reported |
| Number of Participants with changes in abdominal pain | Up to Week 12 (Week 16 if applicable) | Number of participants with self described changes in abdominal pain will be reported |
| Number of Participants with changes in well-being | Up to Week 12 (Week 16 if applicable) | Number of participants with self described changes in well being will be reported |
Countries
United States
Contacts
CONTACTMikki Sandridge
PRINCIPAL_INVESTIGATOREdward Barnes, MD
University of North Carolina, Chapel Hill
Outcome results
None listed