Rifaximin Reduces Number and Severity of Intestinal Lesions Associated With use of Non-steroidal Anti-inflammatory Drugs in Humans

Abstract The intestinal microbiota might contribute to enteropathy associated with use of non-steroidal anti-inflammatory drugs (NSAIDs), but there have been few human studies of this association. We performed a placebo-controlled study to determine whether a delayed release antibiotic formulation (rifaximin-EIR) prevented development of intestinal lesions in persons taking daily NSAIDs. Sixty healthy volunteers (median age 26 years, 42% female) were given the NSAID diclofenac (75 mg twice daily) plus omeprazole (20 mg once daily), and either rifaximin-EIR (400 mg) or placebo, twice daily for 14 days. Subjects were assessed by video-capsule endoscopy at baseline and after 2 weeks of treatment. The primary endpoint was the proportion of subjects developing at least 1 small bowel mucosal break at week 2. Secondary endpoints were the change in mean number of mucosal lesions and number of subjects with large erosions and/or ulcers after 14 days of exposure. We detected mucosal breaks in 20% of subjects given rifaximin and 43% of subjects given placebo ( P =.05. in the post hoc sensitivity analysis). None of the subjects in the rifaximin group developed large lesions, compared with 9 subjects in the placebo group ( P