Probiotic Bif195 helps protect against aspirin-induced stomach damage

The probiotic strain Bifidobacterium breve (Bif195), when co-administered with aspirin, appears to mitigate stomach injury caused by aspirin, according to the results of a randomized crossover trial.

A 4-week course of Bif195 was associated with significantly greater odds of reversing the aspirin-induced changes in the gastric mucosa compared with placebo (odds ratio, 7.2, 95 percent confidence interval, 1.72–30.08; p=0.009), as indicated by lower Lanza scores. On the other hand, during the placebo treatment period, Lanza scores increased significantly from baseline. [Aliment Pharmacol Ther 2023;doi:10.1111/apt.17817]

This finding suggests that “Bif195 … may serve as a safe supplement during multiple-dosing aspirin treatment,” the investigators said.

The analysis included 25 healthy adults (mean age 27.3 years, 56 percent women, mean body mass index 23.2 kg/m²) who underwent a 2-week run-in period before randomization to one of the two intervention sequences: (1) administration of aspirin 300 mg daily plus Bif195 (≥10¹¹ colony-forming units daily) for 28 days, followed by 6 weeks wash-out, and then aspirin plus placebo for 28 days or (2) vice versa.

A gastroduodenoscopy was performed to examine the stomach and the duodenum, with endoscopic findings graded according to the Lanza scale (0: normal mucosal wall; 1: mucosal haemorrhage only; 2: 1-2 erosions; 3: 3-10 areas of erosion; 4: large number of erosions [>10] or ulcer). During the procedure, biopsies were taken from normal and (if present) ulcerated tissue in the stomach and duodenum. Each participant underwent four gastroduodenoscopies during the study.

“The study successfully induced damages to the mucosa in the stomach and/or the duodenum (68 percent), reported as a Lanza score ≥1, after the [aspirin]-challenge. Any damages established in the initial intervention period were reversed in all participants after 6 weeks wash-out at visit 4 (Lanza score = 0),” the investigators noted.

In terms of safety, 34 and 42 adverse events (AEs) were documented during the Bif195 and placebo treatment periods, respectively. The most common AEs were stomachache, sore throat, and bloating, occurring in the 4-day window after gastroduodenoscopy. These events were mostly mild-to-moderate in severity, transient, and consistent with reactions to gastroduodenoscopy and/or aspirin. None of these events were deemed to be associated with Bif195.

Indeed, Bif195 has been granted the Qualified Presumption of Safety status by the European Food Safety Authority and is considered safe for use in food and as food supplement, according to the investigators. [EFSA J 2007;5:1-16]

Like Bif195, bacterial strains such as Lactocaseibacillus casei and Lactobacillus gasseri, among others, have shown promising effects against nonsteroidal anti-inflammatory drug (NSAID)-induced gut damage in humans. [J Gastroenterol 2011;46:894-905; Digestion 2017;95:49-54]

“Altogether, only few studies have shown beneficial effects of probiotics on NSAID-induced gastrointestinal mucosal injury, and Bif195 is, to our knowledge, the first bacterial biotherapeutic that has shown significant reductions in aspirin-induced mucosal injuries in both the stomach and the small intestine,” the investigators said. [Gastroenterology 2019;157:637-646.e4]

While the exact mechanisms behind the beneficial effects of Bif195 are unknown, the investigators postulated that the probiotic strain’s proliferative, anti-inflammatory, and barrier-enhancing properties likely play a role. [Mol Microbiol 2019;111:287-301; Sci Rep 2020;10:1-14; Benef Microbes 2019;10:89-100]