Oral Bif195 protects against ASA-related small-intestinal enteropathy
Oral administration of the Bif195 strain of Bifidobacterium breve reduces the risk of small-intestinal enteropathy in healthy people taking acetylsalicylic acid (ASA), a recent study has shown.
Seventy-five healthy volunteers were randomly assigned to receive either Bif195 (≥5×1010 colony-forming units; n=38; mean age, 30.5±6.8 years; 19 females) or placebo (n=31; mean age, 31.2±6.4 years; 17 females) daily, for an overall duration of 8 weeks. Serial video capsule endoscopy (VCE) was performed to assess small intestinal damage over six visits.
The primary endpoint of Lewis score, calculated as the area under the curve (AUC) for intestinal damage, was significantly lower after 8 weeks in the Bif195 vs placebo arm (3,040±1,340 vs 4,351±3,195 arbitrary units [au]; p=0.0376).
The same was true for AUC for ulcer number, one of the secondary endpoints, which was significantly lower in the Bif195 group (50.4±53.1 vs 75.2±85.3 au; p=0.0258).
Bif195 had no significant protective effects on other secondary endpoints, such as results in the Gastrointestinal Symptom Rating Score, pain, red spots, serum calprotectin and plasma levels of intestinal fatty acid-binding protein.
In terms of safety, 22 participants reported a total of 32 adverse events. Twelve of these events occurred in the Bif195 group, while the remaining 20 were observed from the 20 placebo patients. None were deemed to be related to Bif195, while 10 were assumed to be associated with ASA. The rates of ASA-related adverse events were comparable between treatment arms.