Vonoprazan-amoxicillin dual therapy combined with probiotics for Helicobacter pylori eradication: a prospective, multicenter, randomized controlled trial
Abstract
BACKGROUND: The probiotic may help restore treatment-impaired gut microbiota and promote beneficial bacterial colonization, but its specific impact on Helicobacter pylori (H. pylori) eradication efficacy and safety remains unclear. This study aimed to evaluate the role of Bacillus subtilis dual viable bacteria capsules (Medilac-S) as an adjunct to dual therapy, focusing on its impact on treatment safety and H. pylori eradication efficacy. METHODS: From April 1 to August 1, 2024, 220 H. pylori-positive patients were enrolled. They were randomly assigned to two treatment groups: the Probiotics Group (receiving Medilac-S, two capsules three times daily; vonoprazan 20 mg twice daily; amoxicillin 1000 mg three times daily) and the Dual Therapy Group (vonoprazan 20 mg twice daily; amoxicillin 1000 mg three times daily). Both groups underwent a 14-day treatment course. At least four weeks after treatment completion, a 13C-urea breath test was performed. H. pylori eradication rates, adverse event incidence, and medication compliance were compared between the two groups. RESULTS: Eradication rates did not differ significantly between groups in intention-to-treat (91.8% vs. 90.9%, P = 0.810), modified intention-to-treat (96.2% vs. 94.3%, P = 0.527), or per-protocol analyses (96.1% vs. 95.1%, P = 0.722). However, the Probiotics Group had significantly fewer adverse events (11.4% vs. 23.6%, P = 0.020). Medication compliance showed no significant difference between the groups (P =…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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