Probiotics Show Promise for Symptoms of Functional Gastrointestinal Disorders
Sporulated probiotics were safe and effective in treating symptoms of functional dyspepsia in a small randomized trial in Belgium.
In an intention-to-treat analysis of 55 patients with functional dyspepsia, a greater proportion of those receiving probiotics achieved a clinical response at 8 weeks compared to patients receiving placebo (48% vs. 20%, respectively; RR 1.95, 95% CI 1.07-4.11, P= 0.028), reported Tim Vanuytsel, MD, PhD, of the University Hospitals of Leuven in Belgium, and his colleagues.
Probiotics were also well tolerated, with a similar proportion of the probiotic and placebo groups reporting adverse events, such as gastritis, flu-like symptoms, or skin infections, and no serious treatment-related adverse events, the authors wrote in The Lancet Gastroenterology and Hepatology.
Clinical responses appear to favor the probiotic group regardless of the use of proton pump inhibitors (PPIs):
- With IPP: 46% vs 13%; RR 2.60 (95% CI 0.98-9.36)
- Without PPI: 50% against 27%; RR 1.62 (95% CI 0.78-4.05)
âBecause probiotics are safe and well tolerated, these next-generation spore-forming probiotics can be used early on in the treatment of functional dyspepsia,â said Vanuytsel. MedPage today. “Unfortunately, the therapy is not yet available in the US market.”
Previous treatments for functional dyspepsia have not shown sufficient efficacy or safety. Long-term use of PPI can affect the gut microbiota (causing dysbiosis) and increases the risk of Clostridium difficile infections, noted Vanuytsel and colleagues. One preliminary test probiotics suggested in yogurt (Lactobacillus gasseri) could help treat dyspepsia.
The authors reported that their study is the first to evaluate spore-forming probiotics. Since endospores can survive harsh environments, such as the presence of hydrochloric acid in the stomach, they also have prolonged gut survival, which could make them more efficient, the authors said.
They attempted to assess the safety and efficacy of these probiotics, either given as monotherapy or added to PPIs for the long-term treatment of functional dyspepsia.
From June 2019 to March 2020, the group randomized 68 adults with functional dyspepsia from the same center to receive 2 months of probiotic capsules containing the bacteria Bacillus subtilis (MY02) and Coagulating bacilli (MY01) or placebo twice a day. The probiotic capsules contained 50 mg of 2.5 Ã 109 colony forming units (CFU) of endospores mixed with maltodextrin, a food additive.
Monthly patient PAGI-SYM (patient assessment of upper gastrointestinal symptom severity index) questionnaires assessed symptom severity and quality of life. The primary endpoint was a minimum reduction of 0.7 from Leuven postprandial distress scale in patients with an initial postprandial distress syndrome (PDS) score of at least 1.
The average age of participants was 40, about 75% were female, over 89% were Caucasian, and about half were taking PPIs (a stratification factor). Over 60% of patients presented with PDS. For the analysis of intention-to-treat response, seven patients in the probiotics arm were excluded due to a baseline PDS score
Compared to baseline PDS scores, the decline at 8 weeks was significantly greater in people taking probiotics compared to placebo, although the difference in epigastric pain syndrome scores “was significant with probiotics, but not with probiotics. the placebo, âthe authors noted. PAGI-SYM scores were similar after 8 weeks in both groups.
Probiotics increased bacteria in the stool, Fecalibacterium and Roseburia.
âWe not only found a clinical benefit, but we were also able to gain insight into the mechanism,â Vanuytsel said. “After 16 weeks of treatment, we noticed a decrease in IL-17 and Th17 [T-helper] cells, which are markers of inflammation, and an increase in bacteria in the stool that are known to have beneficial effects on gut health.
The probiotic and placebo groups reported adverse events (16% vs. 33%, respectively). Two serious adverse events, syncope and appendicitis, were also reported, but were unrelated to the study drug, according to the authors. There were no treatment-related deaths.
However, Grace Burns, PhD, of the University of Newcastle in Australia, and her colleagues pointed out several limitations to the findings of a study. accompanying editorial.
“Not all people are receptive to probiotics and the responses are [individualized]: some individuals are probiotic permissive and others are resistant to probiotics, “they wrote.” As such, it remains unclear whether the heterogeneity of the presentation of functional dyspepsia could mean that some under- groups of patients respond better than others to probiotics. “
Limitations of the study noted by the study authors included its limited duration and generalizability. Patients were also not selected based on the severity of the SPD.
“It remains to be seen whether spore-forming probiotic cocktails have long-term efficacy in managing symptoms of functional dyspepsia, and further characterization of immune and microbial profiles at the gastroduodenal level is needed to establish a localized response,” said editorial writers.
Funding for the study was provided by the European Regional Development Fund, a grant from the EOS Foundation for research in Flanders and the Belgian government.
Vanuytsel and the study co-authors declared no competing interests.
Burns did not report any conflicts of interest. A co-author of the editorial reported relationships with Viscera Labs, Microba Life Science, Gossamer Bio, and Anatara Lifesciences.