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Bifidobacterium breve Bif195 Protects Against Small-intestinal Damage Caused by Acetylsalicylic Acid in Healthy Volunteers.

  • 2019-09
  • Gastroenterology 157(3)
    • Brynjulf Mortensen
    • C. Murphy
    • J. O’Grady
    • M. Lucey
    • G. Elsafi
    • L. Barry
    • V. Westphal
    • A. Wellejus
    • O. Lukjancenko
    • A. Eklund
    • H. Nielsen
    • Adam Baker
    • A. Damholt
    • J. V. H. van Hylckama Vlieg
    • F. Shanahan
    • M. Buckley

Abstract

Background & aims: Enteropathy and small-intestinal ulcers are common adverse effects of nonsteroidal 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 breve (Bif195) (≥5 × 1010 colony-forming units) or placebo daily for 8 weeks. Small-intestinal 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 end points 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 group (4351 ± 3195) (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 was determined to be related to Bif195 intake.

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. ClinicalTrials.gov no: NCT03228589.

Keywords: Aspirin; Bacteria; Bleeding; Microbiota.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
BifidobacteriumReduced Incidence of Adverse EventsBeneficial
Small
BifidobacteriumReduced Small-Intestinal EnteropathyBeneficial
Moderate
BifidobacteriumReduced Ulcer CountBeneficial
Moderate
Bifidobacterium breveReduced Incidence of UlcersBeneficial
Moderate
Bifidobacterium breveReduced Small-Intestinal DamageBeneficial
Moderate
Bifidobacterium breve Bb-03Reduced Small-Intestinal DamageBeneficial
Moderate
Bifidobacterium breve Bb-03Reduced Ulcer FormationBeneficial
Moderate
Bifidobacterium breve Bbr8Reduced Small-Intestinal EnteropathyBeneficial
Moderate
Bifidobacterium breve Bbr8Reduced Small-intestinal UlcersBeneficial
Moderate
Bifidobacterium breve BR-03Reduced Small-Intestinal DamageBeneficial
Moderate
Bifidobacterium breve BR-03Reduced Small-intestinal UlcersBeneficial
Moderate
Bifidobacterium breve BR03Reduced Incidence of Adverse EventsBeneficial
Small
Bifidobacterium breve BR03Reduced Incidence of UlcersBeneficial
Moderate
Bifidobacterium breve BR03Reduced Small-Intestinal EnteropathyBeneficial
Moderate
Bifidobacterium breve HA-129Reduced Intestinal DamageBeneficial
Moderate
Bifidobacterium breve HA-129Reduced Ulcers Caused by ASABeneficial
Moderate
Bifidobacterium breve IDCC 4401Reduced Incidence of Adverse EventsBeneficial
Small
Bifidobacterium breve IDCC 4401Reduced Incidence of UlcersBeneficial
Moderate
Bifidobacterium breve IDCC 4401Reduced Small-Intestinal DamageBeneficial
Moderate
Bifidobacterium breve M-16VReduced Incidence of Adverse EventsBeneficial
Small
Bifidobacterium breve M-16VReduced Incidence of UlcersBeneficial
Moderate
Bifidobacterium breve M-16VReduced Small-Intestinal DamageBeneficial
Moderate
Bifidobacterium breve MAK40B22BReduced Intestinal DamageBeneficial
Moderate
Bifidobacterium breve MAK40B22BReduced Ulcer CountBeneficial
Moderate
Bifidobacterium breve R0070Reduced Small-Intestinal DamageBeneficial
Moderate
Bifidobacterium breve R0070Reduced Ulcer CountBeneficial
Moderate
Bifidobacterium breve Rosell-70Reduced Small-Intestinal DamageBeneficial
Moderate
Bifidobacterium breve Rosell-70Reduced Small-intestinal UlcersBeneficial
Moderate
Bifidobacterium breve SD5206Reduced Small-Intestinal DamageBeneficial
Moderate
Bifidobacterium breve SD5206Reduced Small-intestinal UlcersBeneficial
Moderate
Bifidobacterium breve UABbr-11Reduced Incidence of Adverse EventsBeneficial
Small
Bifidobacterium breve UABbr-11Reduced Small-Intestinal DamageBeneficial
Moderate
Bifidobacterium breve UABbr-11Reduced Ulcer CountBeneficial
Moderate
Bifidobacterium breve VPro 52Increased SafetyNeutral
Moderate
Bifidobacterium breve VPro 52Reduced Small-Intestinal DamageBeneficial
Moderate
Bifidobacterium breve VPro 52Reduced Ulcer CountBeneficial
Moderate
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