Effect ofBacillus clausiiCapsules in Reducing Adverse Effects Associated withHelicobacter pyloriEradication Therapy: A Randomized, Double-Blind, Controlled Trial

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 x 10(9)spores ofBacillus clausii(Enterogermina(R); Sanofi Synthelabo) in reducing AEs associated withHelicobacter pylorieradication therapy in Italy. Methods In this randomized, double-blind, single-center, phase IIIB study, 130 adult outpatients withH. pyloriinfection were assigned to receive one Enterogermina(R)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 theB. clausiigroup 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 withB. clausiithan 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 theB. clausiigroup 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, Enterogermina(R)reduced the incidence of, and the number of days with, diarrhea in patients receivingH. pylorieradication therapy. Enterogermina (R) was well tolerated.