Status:
SUSPENDED
Assessment of Patients With Acute Pouchitis Treated With Antibiotics
Lead Sponsor:
Alimentiv Inc.
Conditions:
Pouchitis
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate the reliability and responsiveness of symptoms, endoscopic, and histological items for assessing pouchitis disease activity in patients undergoing standard of ...
Detailed Description
This is a prospective, open-label observational study of patients with acute pouchitis being treated with SOC antibiotic therapy (a known effective therapy in most patients), to evaluate the reliabili...
Eligibility Criteria
Inclusion
- Adult patients ≥ 18 years of age
- IPAA for UC (J-pouch only) ≥ 6 months prior to screening
- Diagnosis of acute pouchitis at screening by stool frequency (an absolute value of ≥ 6 stools / day AND an increase of ≥ 3 stools / day above the post-IPAA baseline), and local endoscopy (presence of ≥ 1 erosion or ulceration of the pouch on endoscopy \[not including ulceration occurring within 1 cm of the pouch staple or pouch suture line\]).
- Not currently taking antibiotics for pouchitis or previous systemic antibiotic use for any reason within 4 weeks of screening. Prior to the Screening pouchoscopy. Note: Initiation of antibiotics for treatment of acute pouchitis prior to the Screening pouchoscopy will be permitted only if the participant initiates treatment within 48 hours prior to the Screening pouchoscopy; use outside of the 48-hour window will not be permitted and these patients should not be included in the study
- Current treatment with 5-aminosalicylic acid drugs, immunosuppressants, antidiarrheals, antimotility agents, and probiotics is permitted, if patient has received a stable dose for ≥ 4 weeks prior to screening. Dose of concomitant therapy must remain stable during the study period.
- Able to participate fully in all aspects of this clinical trial.
- Written informed consent must be obtained and documented
Exclusion
- Pouch formations besides J-pouch (e.g., W-, S- and Kock pouches).
- IPAA for familial adenomatous polyposis.
- Pouchitis caused by other inflammatory etiologies (e.g., ischemia or infection).
- Antibiotic-dependent pouchitis, defined by ≥ 3 months of cumulative antibiotic use over the 12 months prior to screening.
- Isolated cuffitis, pouch-anal or pouch-ileal anastomotic stricture, perforating complications, or pelvic sepsis.
- Known Crohn's disease (CD) or suspected CD of the pouch, defined as complex perianal/pouch fistula and/or extensive length of prepouch ileitis with deep ulceration.
- Anticipated changes in therapy during study period.
- Use of oral corticosteroids. Participants must have discontinued oral corticosteroids within 1 month prior to screening.
- Current use of any advanced oral small molecule drug (e.g Janus kinase \[JAK\] inhibitors for the treatment of pouchitis. Participants must have discontinued oral small molecule therapy within 2 weeks prior to screening.
- Failed (i.e., inadequate response with, loss of response to, or intolerance to) 2 or more compounds or classes of advanced therapies such as biologics and/or small molecule drugs (i.e., 1 biologic and 1 JAK inhibitor, 2 biologics in the same class, or 2 biologics from different classes) for the treatment of pouchitis
- Participant who are pregnant or breastfeeding.
- Known history of allergy, intolerance, or are refractory to ciprofloxacin AND metronidazole AND any component of amoxicillin/potassium clavulanate combination.
- Unable to undergo endoscopic evaluation.
- Serious underlying disease other than acute pouchitis and UC that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study.
- History of alcohol or drug abuse that in the opinion of the investigator may interfere with the participant's ability to comply with the study procedures.
- Prior enrollment in the current study.
Key Trial Info
Start Date :
December 7 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 9 2024
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT05252273
Start Date
December 7 2021
End Date
December 9 2024
Last Update
February 20 2024
Active Locations (4)
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1
Mount Sinai Hospital
New York, New York, United States, 10029
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195
3
Toronto Immune and Digestive Health Institute (TIDHI).
Toronto, Ontario, Canada, M6A 3B4
4
Academic Medical Center Amsterdam.
Amsterdam, Netherlands, C2-319