A CCEPTED MANUSCRIPT
Abstract
Background & Aims: Enteropathy and small-intestinal ulcers are common side effects of non-
steroidal anti-inflammatory drugs such as acetylsalicylic acid (ASA). Safe, cytoprotective strategies
are needed to reduce this risk. Specific Bifidobacteria might have cytoprotective activities, but little
is known about these effects in humans. We used serial video capsule endoscopy (VCE) to assess
the efficacy of a specific Bifidobacterium strain in healthy volunteers exposed to ASA.
Methods: We performed a single-site, double-blind, parallel-group, proof of concept analysis of 75
heathy volunteers given ASA (300 mg) daily for 6 weeks, from July 31 through October 24, 2017.
The participants were randomly assigned (1:1) to groups given oral capsules of Bifidobacterium
10 colony forming units) or placebo, daily for 8 weeks. Small-intestinal
breve (Bif195; ≥ 5*10
damage was analyzed by serial VCE at 6 visits. The area under the curve (AUC) for intestinal
damage (Lewis score) and the AUC value for ulcers were the primary and first-ranked secondary
MANUSCRIPT
endpoint of the trial, respectively.
Results: Efficacy data were obtained from 35 participants given Bif195 and 31 given placebo. The
AUC for Lewis score was significantly lower in the Bif195 group (3040 ± 1340 arbitrary units) than
the placebo (4351 ± 3195 arbitrary units) ( P =.0376). The AUC for ulcer number was significantly
lower in the Bif195 group (50.4 ± 53.1 arbitrary units) than in the placebo group (75.2 ± 85.3
arbitrary units) ( P =.0258). Twelve adverse events were reported from the Bif195 group and 20 from
the placebo group. None of the events were determined to be related to Bif195 intake.
ClinicalTrials.gov no: NCT03228589
Conclusions: In a randomized double-blind trial of healthy volunteers, we found oral Bif195 to
safely reduce the risk of small-intestinal enteropathy caused by ASA.
KEY WORDS: aspirin, bacteria, microbiota, bleeding
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