Effect of Bacillus clausii Capsules in Reducing Adverse Effects Associated with Helicobacter pylori Eradication Therapy:
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ORIGINAL RESEARCH
Effect of Bacillus clausii Capsules in Reducing Adverse Effects Associated with Helicobacter pylori Eradication Therapy: A Randomized, Double-Blind, Controlled Trial Manuel Plomer . Marcos Perez III . Dorothea Maren Greifenberg
Received: July 16, 2020 Ó The Author(s) 2020
ABSTRACT Introduction: Antibiotic treatment can alter the gut microbiome and cause short-term gastrointestinal adverse effects (AEs). This study assessed the efficacy of lyophilized capsules containing 2 9 109 spores of Bacillus clausii (EnterogerminaÒ; Sanofi Synthelabo) in reducing AEs associated with Helicobacter pylori eradication therapy in Italy. Methods: In this randomized, double-blind, single-center, phase IIIB study, 130 adult outpatients with H. pylori infection were assigned to receive one EnterogerminaÒ capsule or placebo three times daily for 2 weeks (1:1). During week 1, all patients received clarithromycin 500 mg, amoxicillin 1 g, and rabeprazole 20 mg twice daily. The primary efficacy outcome was the presence of diarrhea in week 1.
Results: A total of 130 patients were randomized. The incidence of diarrhea in week 1 was 29% in the B. clausii group and 48% in the placebo group [relative risk (RR) 0.61; 95% confidence interval (CI) 0.39–0.97; p = 0.03]. The incidence of diarrhea remained lower with B. clausii than with placebo in week 2 (RR 0.38; 95% CI 0.14–1.02; p = 0.0422). In week 1, the number of days without diarrhea was significantly higher in the B. clausii group than in the placebo group (6.25 vs. 5.86; p = 0.0304). In both groups, the number of days without diarrhea increased significantly (p \ 0.0001) from week 1 to week 2. A total of three AEs occurred in two patients in the placebo group, but none were serious. Conclusions: Compared with placebo, EnterogerminaÒ reduced the incidence of, and the number of days with, diarrhea in patients receiving H. pylori eradication therapy. EnterogerminaÒ was well tolerated. Keywords: Bacillus clausii; Clinical trial; Diarrhea; Enterogermina; Eradication therapy; Helicobacter pylori; Probiotics
Digital Features To view digital features for this article go to https://doi.org/10.6084/m9.figshare.12841409. M. Plomer M. Perez III D. M. Greifenberg (&) Consumer Healthcare, Sanofi-Aventis Deutschland ¨ chst, Frankfurt am Main, GmbH, Industriepark Ho Germany e-mail: [email protected]
Infect Dis Ther
INTRODUCTION Key Summary Points Why carry out this study? Recommended antibiotic treatments for Heliobacter pylori eradication cause shortterm gastrointestinal adverse effects (AEs), such as diarrhea, nausea, vomiting, bloating, and abdominal pain. Such AEs can result in treatment discontinuation, and may increase the risk of treatment failure and/or developing antibiotic resistance. This study aimed to assess and confirm the efficacy of a spore-based probiotic containing spores of four antibioticresistant B. clausii strains (EnterogerminaÒ) in reducing and preventing the AEs associated with H. pylori eradication therapy using the galenic form of capsul
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