Effects of Bifidobacterium animalis ssp. lactis 420 on gastrointestinal inflammation induced by a non-steroidal anti-inflammatory drug: a randomized, placebo-controlled, double-blind clinical trial.

AIMS Use of non-steroidal anti-inflammatory drugs (NSAIDs) can cause damage to the gastric and duodenal mucosa. Some probiotics have proven useful in ameliorating the harmful side-effects of NSAIDs. Our aim was to evaluate whether oral administration of Bifidobacterium animalis ssp. lactis 420 (B420) can attenuate the increase of calprotectin excretion into faeces induced by intake of diclofenac sustained-release tablets. METHODS A double-blind, parallel-group, placebo-controlled and randomized clinical study was performed in 50 healthy male and female volunteers aged 20 to 40 years, in Finland. Study participation consisted of four phases: run-in, intervention with B420 or placebo, B420 or placebo + NSAID treatment, and follow-up. The primary outcome was the concentration of calprotectin in faeces. Secondary outcomes were haemoglobin and microbial DNA in faeces and blood haemoglobin levels. RESULTS Intake of diclofenac increased the faecal excretion of calprotectin in both groups. The observed increases were 48.20±61.55 μg/g faeces (mean ± SD) in the B420 group and 31.30±39.56 μg/g in the placebo group (difference estimate 16.90; 95% CI: -14.00, 47.77; p=0.276). There were no significant differences between the treatment groups in changes of faecal or blood haemoglobin. Faecal Bifidobacterium lactis DNA was much more abundant in the B420 group compared to the placebo group (ANOVA estimate for treatment difference 0.85 x 109 /g faeces; 95% CI: 0.50 x 109 , 1.21 x 109 ; p<0.0001). CONCLUSION Short-term administration of the probiotic B420 did not protect the healthy adult study participants from diclofenac-induced gastrointestinal inflammation as determined by analysis of faecal calprotectin levels.