NCT05252273

Assessment of Patients With Acute Pouchitis Treated With Antibiotics

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

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 43 (estimated)
• Sponsor: Alimentiv Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 reliability and responsiveness of existing pouchitis indices and component items for assessing pouchitis disease activity. A total of 43 subjects will be recruited and enrolled at clinical sites in North America and Europe. All subjects with suspected acute pouchitis will undergo pouchoscopy with biopsies and blood and stool sample collection at screening and receive 28 days of antibiotic therapy. Subjects will return to the clinic for a follow-up clinical assessment, pouchoscopy with biopsies forendoscopic and histologic assessments of disease activity, respectively, and blood and stool sample collection for inflammatory biomarker, molecular, and microbiome analyses approximately 6 weeks after starting antibiotic therapy. Subjects will collect an additional stool sample for fecal calprotectin (FC) and microbiome analyses and metabolomics at Week 4 and return the sample to the clinic in person or by mail. Subjects will rate their pouchitis symptoms in an electronic diary beginning at least 3 days before initiation of antibiotic therapy through to the Week 6 study visit. Total anticipated duration of subject participation is approximately 6 weeks after initiating antibiotic therapy. Endoscopic and Histologic Disease Activity Assessments: Blinded expert endoscopists and histopathologists will serve as central readers for this study and score pouchoscopy videos and histologic slide images, respectively. Paired pouchoscopy videos and histologic slide images (baseline and Week 6) of adequate quality will be scored by central readers (see Outcome Measures). Each central reader will score all Week 6 pouchoscopy videos and histologic slide images twice, 2 weeks apart, for assessing reliability, and all baseline pouchoscopy videos/slide images once to be compared to scores posttreatment scores for assessing responsiveness. Novel Pouchitis Disease Activity Index Development: A novel index will be developed using multiple linear regression with items that have moderate reliability and responsiveness. The index will be internally validated using the bootstrap method with 2000 replicates. Primary Objective: The primary objective of this study is to evaluate the reliability and responsiveness of patient-reported symptoms and endoscopic and histologic items for assessing pouchitis disease activity in patients undergoing standard of care (SOC) antibiotic therapy. Secondary Objective: A secondary objective of this study is to develop a novel index for assessing pouchitis disease activity. Exploratory Objectives: 1. Identify biomarkers associated with (non)response to antibiotics in pouchitis; 2. Identify biomarkers associated with patient-reported symptoms, endoscopic, and histologic component scores and items, and pouchitis disease activity indices; 3. Describe the dynamics of the microbiome following introduction and withdrawal of antibiotics in pouchitis. Additional exploratory analyses may be established during the review of the study results.

Conditions

• Pouchitis
• Ulcerative Colitis

Interventions

Type	Name	Description
OTHER	Observational, No intervention	Open-label observational study that will evaluate the reliability and responsiveness of patient-reported symptoms and endoscopic and histologic items for assessing pouchitis disease activity in 43 patients undergoing standard of care (SOC) antibiotic therapy.

Timeline

• Start date: 2021-12-07
• Primary completion: 2024-02-12
• Completion: 2024-12-09
• First posted: 2022-02-23
• Last updated: 2024-02-20

Locations

4 sites across 3 countries: United States, Canada, Netherlands