Clinical Trial: Clotrimazole Enemas for Pouchitis in Children and Adults

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: Clotrimazole Enemas for Pouchitis in Children and Adults

Brief Summary:

Colectomy with creation of an ileal pouch (IPAA) is now the treatment of choice for patients with ulcerative colitis that is resistant to existing medical therapies. The development of inflammation in these ileal reservoirs, a clinical entity referred to as pouchitis, is the most common long-term complication of this procedure and can affect 50-60% of adults and children. We have previously demonstrated that clotrimazole (delivered as a rectal suppository) is generally safe, effective, and displays poor systemic absorption when used in pediatric and adults with active pouchitis. We saw clinical benefit in patients with pouch disease that had previously failed to respond to standard antibiotic, steroid, or immunosuppressive therapies. The clinical trial outlined here will define the effectiveness and safety of topical clotrimazole therapy (delivered as a rectal enema) in pediatric (aged greater than two years) and adult patients with pouchitis.

Subjects in this study will be randomly assigned to receive either placebo (no active drug, 4 subjects) or one of two clotrimazole therapy groups: 2500 mg/day (8 subjects) or 4000mg/day (8 subjects). No washout period is required, and subjects will be allowed to continue their existing anti-inflammatory medications during their participation in the study. Clotrimazole will be delivered nightly in the form of an enema. Subjects will undergo flexible sigmoidoscopy (pouchoscopy) prior to and again after completing one month of study therapy, and pouch disease activity will be graded at after each procedure using the Pouchitis Disease Activity Index (PDAI). Clinical improvement will be defined as a drop in PDAI score. If the drop in PDAI scores between placebo and either active clotrimazole treatment group is not significant, and no subject experiences what are determined to be study-related adverse effects, a second cohort of subjects

Detailed Summary:
Sponsor: Paul Rufo

Current Primary Outcome: Improvement in Pouchitis Disease Activity Index (PDAI) [ Time Frame: 30 Days ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Boston Children’s Hospital

Dates:
Date Received: May 23, 2003
Date Started: September 2002
Date Completion: June 2018
Last Updated: January 26, 2016
Last Verified: January 2016