Abstract

Introduction: Low-dose aspirin (50-325 mg daily) is widely recommended for the prevention of cardiovascular disease. However, daily use of aspirin is associated with an increased risk of gastrointestinal mucosal damage including gastric and duodenal ulcers. We have recently published data on the ability of the probiotic Bifidobacterium breve , Bif195, to reduce aspirin-induced epithelial damage in the small intestine, as evaluated by capsule endoscopy. However, it remains undetermined whether Bif195 alters aspirin-induced mucosa damage in the gastric ventricle, representing a more aspirin-exposed area and hostile environment for probiotics. Methods: In a 2x4 week double-blinded, placebo-controlled, randomized, crossover clinical trial, 25 healthy men and women were asked to take a daily oral dose of 300 mg aspirin during both intervention periods, and randomized to a sequence of daily oral intake of Bifidobacterium breve , Bif195≥ 10 11 colony forming units) capsules and placebo capsules, separated by a 6 weeks washout period. Participants were subjected to a gastroduodenoscopy immediately before and in the end of each intervention period. All gastroduodenoscopies were performed by the same gastroenterologist. The primary endpoint was change in Lanza score (0-5). Furthermore, mucosal biopsies, luminal fluids and blood samples were collected. Results: Gastrointestinal damage was absent in all subjects at baseline (Lanza score 0). The score was significantly reduced with Bif195 compared to placebo, in the Gastric ventricle. Values after treatment, see the table. Conclusion: Aspirin-induced gastric mucosa damage is significantly ameliorated by intake of Bif195 resulting in a 3 times lower Lanza score compared to placebo, whereas no statistically significant difference was observed in the duodenum. Bif195 may represent a beneficial supplement to continuous aspirin treatment reducing risk of aspirin-induced upper GI mucosa damage and ulcer formation.

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