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DOI: 10.1055/s-0035-1551703
A double-blind, randomized, placebo-controlled video capsule endoscopy trial on the safety and efficacy of Rifaximin-EIR 800 mg BID to prevent intestinal injury caused by a two-weeks-treatment of diclofenac SR 75 mg BID plus omeprazole 20 mg OD in 60 healthy volunteers
Background:
Proton pump inhibitors (PPIs) may worsen non-steroidal anti-inflammatory drug (NSAID) induced enteropathy by impairing the intestinal microbiota. Rifaximin is an antimicrobial drug which covers a broad spectrum of enteric pathogens. The aim of this study was to evaluate the safety and efficacy of Rifaximin-EIR, a delayed-release formulation of coated microgranules of rifaximin, to prevent small bowel lesions in healthy volunteers receiving NSAIDs and PPIs.
Methods:
In this double-blind, randomized, placebo-controlled, phase-I/II trial (EudraCT 2013 – 000730 – 36) healthy volunteers were randomized to receive diclofenac SR 75 mg BID plus omeprazole 20 mg OD plus either Rifaximin-EIR 800 mg or Rifaximin-EIR matching placebo BID for 14 days. Video capsule endoscopy (VCE) was performed at baseline and after treatment to assess intestinal injury.
Findings:
60 subjects were randomized (30 per group). In the modified Full Analysis (all randomized subjects undergoing final VCE) 6 subjects receiving Rifaximin-EIR and 13 subjects receiving placebo developed at least one mucosal lesion (erosion or ulcer) in the small bowel (odds ratio (OR) of 0.3269 [95% CI 0.1035, 1.0322]; p-value = 0.0566). A protective effect of Rifaximin-EIR on the mean changes of mucosal lesions from baseline was observed (treatment effect point estimate -1.4137 [95% CI -2.4935, -0.3339]; p-value = 0.0103. Concerning safety, 26 and 40 treatment-related adverse events were observed with Rifaximin-EIR (14 [45.2%] subjects) and placebo (18 [60.0%] subjects), respectively.
Interpretation:
In this study, Rifaximin-EIR proved to be safe and effective for the protection against NSAID induced intestinal injury in healthy volunteers. These findings need to be confirmed in regular NSAID users.
Funding:
This study was sponsored by Alfa Wassermann S.p.A.