Spore-forming probiotics are safe and effective for treating functional dyspepsia, according to a small pilot study from Belgium.

The single-centre, randomised, double-blind, placebo-controlled pilot trial analysed the safety and efficacy of probiotics in functional dyspepsia as monotherapy or add-on therapy to long-term treatment with proton-pump inhibitors (PPIs).

The study included 68 patients with functional dyspepsia who were randomised to treatment with probiotics (Bacillus coagulans MY01 and Bacillus subtilis MY02, 2·5 × 10⁹ colony-forming units per capsule) of endospores mixed with maltodextrin [food additive]) or placebo consumed twice daily, followed by an open-label extension phase of 8 weeks. Those with a history of abdominal surgery, diabetes, celiac or inflammatory bowel disease, active psychiatric conditions and use of immunosuppressant drugs, antibiotics, or probiotics in the past 3 months were not included in the study group. 

The decline in baseline postprandial distress syndrome (PDS) scores at 8 weeks was higher in patients who were given probiotics (48%) compared to patients who received placebo (20%). PAGI-SYM (patient assessment of upper gastrointestinal symptom severity index) scores were similar after 8 weeks in both groups.

When evaluated as an add-on therapy, the observed clinical response was higher in the probiotic group, whether they were taking PPI or not. With PPI, the clinical response was 46% vs 13%; without PPIs, the clinical response was 50% vs 27% favoring probiotics.

The administered probiotics were also well-tolerated; no between-group differences were observed. The common side effects reported were flu-like symptoms, gastritis or skin infections.

Besides their clinical benefit, the study also shed some light on their anti-inflammatory action as evident by a decrease in inflammatory markers (IL-17 and Th17) after 16 weeks of treatment.

The health benefits of probiotics have been well-documented and their potential beneficial health effects are being continuously researched. This small pilot study has added to the growing evidence. According to the authors, this is the first study to investigate spore-forming probiotics. “Since endospores can survive harsh environments, such as the presence of hydrochloric acid in the stomach, they also have prolonged intestinal survival, which could make them more effective”, they said.

(Source: Medpage Today August 6, 2021 & The Lancet Gastroenterology and Hepatology, August 3, 2021)

Dr Sanjay Kalra, DM, Bharti Hospital, Karnal; Immediate Past President, Endocrine Society of India 

Dr. Pawan Rawal, Head, Gastroenterology, Centre of Excellence for Digestive & Liver Diseases, Artemis Hospital, Gurgaon