Assessment of Patients With Acute Pouchitis Treated With Antibiotics

ID#: NCT05252273

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: December 07, 2021

End Date: December 07, 2023

Contact Information:
Danusha Nanda
(226) 270 7833
Robyn Garrels
(226) 224 4750
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 care (SOC) antibiotic therapy for treatment of pouchitis, in order to develop a novel pouchitis disease activity index.

Eligibility:



Inclusion Criteria:

- Male or female 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.

- Current treatment with 5-aminosalicylic acid drugs, immunosuppressants, antidiarrheals, antimotility agents, and probiotics is permitted, if subject has received a stable dose for ≥ 4 weeks prior to screening. Dose of concomitant therapy must remain stable during the study period.

- Ability of subject to participate fully in all aspects of this clinical trial.

- Written informed consent must be obtained and documented

Exclusion Criteria:

- 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. Subjects must have discontinued oral corticosteroids within 1 month of screening.

- Current use of any biological therapy (e.g., anti-tumour necrosis factor (TNF) therapies, ustekinumab, vedolizumab) or advanced oral small molecule drug (e.g., Janus kinase [JAK] inhibitors). Subjects must have discontinued biologic or oral small molecule therapy within 12 weeks or 5 half-lives of screening (or within 4 weeks if drug levels are undetectable).

- Failure of ≥ 2 biologics (i.e., biologic and JAK inhibitor, 2 biologics in the same class, or 2 biologics from different classes) for the treatment of pouchitis.

- Women 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 subject'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 subject's ability to comply with the study procedures.

- Prior enrolment in the current study.