The efficacy of the nonabsorbable antibiotic rifaximin in patients with active acute or chronic pouchitis is unknown.
Dr Kim Isaacs and colleagues from North Carolina, USA performed a placebo-controlled pilot trial to evaluate the efficacy and safety of rifaximin in patients with active pouchitis.
The team reported that 18 patients with active pouchitis were randomized to receive oral rifaximin 400 mg or placebo 3 times daily for 4 weeks.
|25% treated with rifaximin were in remission at week 4|
|Inflammatory Bowel Diseases|
Active pouchitis was defined as a total Pouchitis Disease Activity Index score of 7 points.
The team defined clinical remission as a Pouchitis Disease Activity Index score less than 7 points, and a decrease in the baseline Pouchitis Disease Activity Index score by 3 points.
The primary analysis was clinical remission at week 4.
The team randomized 8 patients to rifaximin, and 10 patients to placebo.
The investigators noted that 1 patient in the placebo group did not have a post-baseline efficacy evaluation, and was excluded from the efficacy analysis.
The investigative team found that 25% of patients treated with rifaximin were in clinical remission at week 4 compared to none treated with placebo.
None of 8 patients in the rifaximin group withdrew from the trial prior to week 4.
The team observed that 2 of 9 patients in the placebo group withdrew prior to week 4 due to lack of efficacy and were categorized as treatment failures.
Dr Isaacs' team concluded, "Clinical remission occurred more frequently in patients treated with rifaximin 400 mg 3 times daily but the difference was not significant in this pilot study."
"A larger trial would be required to determine if rifaximin is effective for the treatment of active pouchitis."
"Rifaximin was well tolerated."