Spore-Forming Probiotics Safe and Effective for Functional Dyspepsia

Probiotic bacteria
Probiotic bacteria
Investigators assessed the safety and efficacy of treatment with spore-forming probiotics in reducing symptoms of functional dyspepsia.

Spore-forming probiotics Bacillus coagulans (B coagulans) MY01 and Bacillus subtilis (B subtilis) MY02 were safe and effective for the treatment of functional dyspepsia, according to a study published in The Lancet Gastroenterology and Hepatology.

The randomized, double-blind, placebo-controlled trial included 68 patients with functional dyspepsia (ClinicalTrials.gov Identifier: NCT04030780). Patients in the treatment arm received the probiotics B coagulans MY01 and B subtilis MY02 twice daily for 8 weeks. After the first 8 weeks, the study included an 8-week open-label extension. Approximately 50% of patients, evenly distributed at randomization, took proton pump inhibitors prior to the study and continued usage during the trial.

The primary endpoint of the study was the proportion of clinical responders, defined as a decrease of 0.7 or greater in the postprandial distress syndrome score of the Leuven Postprandial Distress Scale. Secondary endpoints included clinical responders with a lower defined decrease, changes in biological endpoints, such as C-reactive protein and fecal microbiota, and the progression of responder rates on a weekly basis.

Probiotic usage was associated with a higher rate of clinical responders compared with placebo, with a relative risk of 1.95 [95% CI, 1.07–4.11]; P =.028). Treatment with probiotics reduced the number of positive glycocholic acid breath tests in patients taking proton pump inhibitors. This correlation suggests a reduction in small intestinal bacterial overgrowth. There was no significant difference in the adverse events between groups.

This study was limited by the small sample size, and results may be affected by confounding factors that were not assessed, such as dietary intake.

Investigators believe additional studies will enhance these results and “establish the positions of probiotics as an add-on to proton-pump inhibitors or monotherapy in functional dyspepsia.”


Wauters L, Slaets H, De Paepe K, et al. Efficacy and safety of spore-forming probiotics in the treatment of functional dyspepsia: a pilot randomized, double-blind, placebo-controlled trial. Lancet Gastroenterol Hepatol. Published online August 3, 2021. doi: 10.1016/S2468-1253(21)00226-0