The efficacy and safety of Clostridium butyricum and Bacillus coagulans in Helicobacter pylori eradication treatment: An open-label, single-arm pilot study

BACKGROUND: Helicobacter pylori (H pylori) infection plays a critical role in gastritis-associated diseases, gastroduodenal ulcers, and even gastric cancer. Studies have shown that probiotics may exhibit antagonistic activity against H pylori. METHODS: This study aimed to assess the efficacy and safety of monotherapy with Clostridium butyricum (C butyricum) and Bacillus coagulans (B coagulans) for H pylori treatment. Our research was an open-label, single-arm pilot study of H pylori eradication. Subjects diagnosed with H pylori infection as outpatients at Xijing Hospital were randomized (1:1:1) to receive 8 weeks of therapy with C butyricum (group A), B coagulans (group B), or C butyricum plus B coagulans (group C). H pylori status was assessed 1 to 2 weeks after treatment. The H pylori eradication rate according to intention-to-treat and per-protocol analyses was the primary outcome of study, and the delta over baseline score, adverse events, and compliance were the secondary outcomes. This study was registered at ClinicalTrials.gov (NCT 03857425). RESULTS: A total of 150 subjects were consecutively enrolled from February 2019 to August 2019. The ITT analysis demonstrated that the 3 groups achieved similar eradication rates (18%, 20%, and 26%, respectively, P = .597). The PP analysis yielded a similar result (24.3%, 26.3%, and 32.5%, respectively, P = .703). None of the subjects reported adverse events during treatment. The 3 groups had comparable compliance rates (74% vs 76% vs 80%, P > .05). CONCLUSION: C butyricum and B coagulans may effectively inhibit H pylori to some extent, with rare adverse events, and thus may reduce the burden of antibiotic resistance.