Bacillus coagulans, Bacillus subtilis effective in functional dyspepsia treatment
“First-line therapy for functional dyspepsia is acid suppression with [proton-pump inhibitors (PPIs)]. ... Previous studies suggested efficacy of probiotics for PPI-related side effects and uninvestigated dyspeptic symptoms, which could be caused by an altered small intestinal microbiome,” Lucas Wauters, MD, University Hospitals Leuven, and colleagues wrote. “Despite beneficial effects of Bacillus coagulans and Bacillus subtilis strains on gut permeability and inflammation in in vitro models, clinical trials on the effect of spore-forming probiotics are absent in human disorders with similar alterations, including functional dyspepsia.”
In a single-center, randomized, double-blind pilot trial, researchers analyzed 68 patients (75% women, mean age 40 years, 50% on PPIs) with functional dyspepsia to assess the safety and efficacy of spore-forming probiotics as a monotherapy or add-on therapy to long-term treatment with PPIs. Patients received either the probiotic treatment of 1:1 combined spray-dried B. coagulans MY01 and B. subtilis MY02 endospores in a mixture of 50 mg with 300 mg maltodextrin twice daily (n = 32) or placebo (350 mg maltodextrin) twice daily for 8 weeks, followed by an 8-week open-label extension phase. Researchers recorded symptoms, immune activation and fecal microbiota; the primary endpoint was a decreased postprandial distress syndrome score of at least 0.7.
According to study results, the proportion of clinical responders was higher for probiotics vs. placebo (48% vs. 20%; RR = 1.95; 95% CI, 1.07-4.11). Further, response with probiotics was not significantly higher when comparing PPI use with no PPI use (RR = 1.62; 95% CI, 0.78-4.05). Researchers noted a similar number of patients experienced adverse events among both groups (5 vs. 12, respectively).
“The current combination of B. coagulans MY01 and B. subtilis MY02 spore-forming probiotics was effective and safe in patients with functional dyspepsia,” Wauters and colleagues concluded. “Although spore-forming probiotics could be considered as monotherapy, changes in immune activation were more pronounced with probiotics in patients with functional dyspepsia on PPIs, suggesting additional beneficial effects on chronic alterations with PPI therapy. This pilot study underscores the potential role of microbiota in functional dyspepsia. ... Future studies should strengthen this preliminary evidence for spore-forming probiotics in different populations and functional dyspepsia subtypes.”