Bifidobacterium animalis subsp. lactis BLa80 regulates the intestinal habit in adults with chronic constipation: a multicentre, randomised, double-blind, placebo-controlled study.

Treatment with probiotics can help manage chronic constipation by softening the stools and possibly acting synergistically with front-line treatments. We assessed the efficacy of Bifidobacterium animalis subsp. lactis BLa80 in maltodextrin as a food supplement in regulating the intestinal habit of subjects with chronic constipation with type 1 or 2 stools on the Bristol scale index and/or less than three stools per week. A multicentre, randomised, double-blind, placebo-controlled clinical trial was carried out in subjects aged 18 and over with chronic constipation. The study enrolled forty-six subjects who were randomised one-to-one to receive the potential probiotic in maltodextrin (n = 23) or a placebo (n = 23). Investigators assessed changes in intestinal habits by analysing the mean number of weekly stools and the stool types according to the Bristol Scale. Patients reported constipation symptoms with PAC-SYM (patient assessment of constipation - symptoms), and the impact on quality of life with PAC-QoL (patient assessment of constipation - quality of life) and GI-QLI (gastrointestinal quality of life index). Patients on the intervention group showed a greater tendency to normalise the type of stools than those in the placebo group. This difference towards regular stool types (type 3 and 4) was statistically significant at weeks 8 and 12 relative to week 4 (P-values = 0.006 and 0.027, respectively). The proportion of constipated patients in the experimental group dropped over time, while the rate slightly increased in the placebo group in a statistically significant manner at week 12 relative to week 4 ( P = 0.037). Overall, the present study shows oral intake of B. animalis subsp. lactis BLa80 in maltodextrin for 12 weeks improves intestinal habits in subjects with chronic constipation. Our study provides evidence to the efficacy and safety use of this formulation as an effective tool for improving stool consistency in constipated patients. The trial was registered at ClinicalTrials.gov: NCT05980988.