Assessment of Patient-reported Symptoms and Endoscopic, Histologic, and Biomarker Outcomes in Patients With Acute Pouchitis Treated with Antibiotics

• Conditions: Acute Pouchitis; Inflammatory bowel disease; 10017969

• Registration Number: NL-OMON54456
• Lead Sponsor: Alimentiv B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

Participants must meet each of the following criteria for enrollment into the
study:
1. Adults >=18 years of age.
2. Ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC) (J-pouch
only) >= 6 months prior to screening.
3. Diagnosis of acute pouchitis at screening by stool frequency (an absolute
value of >= 6 stools / day ANDan 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]).
4. Not currently taking antibiotics for pouchitis and no previous systemic
antibiotic use for any reason within 4 weeks 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.
5. 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.
6. Able to participate fully in all aspects of this clinical study.
7. Written informed consent must be obtained and documented.

Exclusion Criteria

Participants who exhibit any of the following conditions are to be excluded
from the study:
1. Pouch formations besides J-pouch (e.g., W-, S- and Kock pouches).
2. IPAA for familial adenomatous polyposis.
3. Pouchitis caused by other inflammatory etiologies (e.g., ischemia or
infection).
4. Antibiotic-dependent pouchitis, defined by >= 3 months of cumulative
antibiotic use over the 12 months prior to screening.
5. Isolated cuffitis, pouch-anal or pouch-ileal anastomotic stricture,
perforating complications, or pelvic sepsis.
6. 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.
7. Anticipated changes in therapy during study period.
8. Use of oral corticosteroids. Participants must have discontinued oral
corticosteroids within 1 month prior to screening.
9. 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.
10. 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.
11. Participants who are pregnant or breastfeeding.
12. Known history of allergy, intolerance, or are refractory to ciprofloxacin
AND metronidazole AND any component of amoxicillin/potassium clavulanate
combination.
13. Unable to undergo endoscopic evaluation.
14. 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.
15. 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.
16. Prior enrollment in the current study.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified