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
- PubMed: 31095949
- DOI: 10.1053/j.gastro.2019.05.008
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
| Supplement | Health Outcome | Effect Type | Effect Size |
|---|---|---|---|
| Bifidobacterium | Reduced Incidence of Adverse Events | Beneficial | Small |
| Bifidobacterium | Reduced Small-Intestinal Enteropathy | Beneficial | Moderate |
| Bifidobacterium | Reduced Ulcer Count | Beneficial | Moderate |
| Bifidobacterium breve | Reduced Incidence of Ulcers | Beneficial | Moderate |
| Bifidobacterium breve | Reduced Small-Intestinal Damage | Beneficial | Moderate |
| Bifidobacterium breve Bb-03 | Reduced Small-Intestinal Damage | Beneficial | Moderate |
| Bifidobacterium breve Bb-03 | Reduced Ulcer Formation | Beneficial | Moderate |
| Bifidobacterium breve Bbr8 | Reduced Small-Intestinal Enteropathy | Beneficial | Moderate |
| Bifidobacterium breve Bbr8 | Reduced Small-intestinal Ulcers | Beneficial | Moderate |
| Bifidobacterium breve BR-03 | Reduced Small-Intestinal Damage | Beneficial | Moderate |
| Bifidobacterium breve BR-03 | Reduced Small-intestinal Ulcers | Beneficial | Moderate |
| Bifidobacterium breve BR03 | Reduced Incidence of Adverse Events | Beneficial | Small |
| Bifidobacterium breve BR03 | Reduced Incidence of Ulcers | Beneficial | Moderate |
| Bifidobacterium breve BR03 | Reduced Small-Intestinal Enteropathy | Beneficial | Moderate |
| Bifidobacterium breve HA-129 | Reduced Intestinal Damage | Beneficial | Moderate |
| Bifidobacterium breve HA-129 | Reduced Ulcers Caused by ASA | Beneficial | Moderate |
| Bifidobacterium breve IDCC 4401 | Reduced Incidence of Adverse Events | Beneficial | Small |
| Bifidobacterium breve IDCC 4401 | Reduced Incidence of Ulcers | Beneficial | Moderate |
| Bifidobacterium breve IDCC 4401 | Reduced Small-Intestinal Damage | Beneficial | Moderate |
| Bifidobacterium breve M-16V | Reduced Incidence of Adverse Events | Beneficial | Small |
| Bifidobacterium breve M-16V | Reduced Incidence of Ulcers | Beneficial | Moderate |
| Bifidobacterium breve M-16V | Reduced Small-Intestinal Damage | Beneficial | Moderate |
| Bifidobacterium breve MAK40B22B | Reduced Intestinal Damage | Beneficial | Moderate |
| Bifidobacterium breve MAK40B22B | Reduced Ulcer Count | Beneficial | Moderate |
| Bifidobacterium breve R0070 | Reduced Small-Intestinal Damage | Beneficial | Moderate |
| Bifidobacterium breve R0070 | Reduced Ulcer Count | Beneficial | Moderate |
| Bifidobacterium breve Rosell-70 | Reduced Small-Intestinal Damage | Beneficial | Moderate |
| Bifidobacterium breve Rosell-70 | Reduced Small-intestinal Ulcers | Beneficial | Moderate |
| Bifidobacterium breve SD5206 | Reduced Small-Intestinal Damage | Beneficial | Moderate |
| Bifidobacterium breve SD5206 | Reduced Small-intestinal Ulcers | Beneficial | Moderate |
| Bifidobacterium breve UABbr-11 | Reduced Incidence of Adverse Events | Beneficial | Small |
| Bifidobacterium breve UABbr-11 | Reduced Small-Intestinal Damage | Beneficial | Moderate |
| Bifidobacterium breve UABbr-11 | Reduced Ulcer Count | Beneficial | Moderate |
| Bifidobacterium breve VPro 52 | Increased Safety | Neutral | Moderate |
| Bifidobacterium breve VPro 52 | Reduced Small-Intestinal Damage | Beneficial | Moderate |
| Bifidobacterium breve VPro 52 | Reduced Ulcer Count | Beneficial | Moderate |