Combination of gastroprotectors and probiotics in the eradication of H. pylori infection: results of a randomized comparative clinical trial

Abstract

Objective. To compare efficacy and safety of 14-day triple eradication therapy with the addition of methylmethionine sulfonium chloride and a probiotic complex and 14-day triple eradication therapy boosted with bismuth tripotassium dicitrate and a probiotic complex in a prospective comparative randomized clinical trial. Materials and Methods. A total of 70 patients with confirmed H. pylori infection were enrolled into the study. The first group (n = 35) received esomeprazole 20 mg 2 bid, clarithromycin 500 mg bid and amoxicillin 1000 mg bid for 14 days, methylmethionine sulfonium chloride 300 mg once a day for 1 month, probiotic complex (bifidobacteria [Bifidobacterium longum CBT BG7, Bifidobacterium lactis CBT BL3, Bifidobacterium bifidum CBT BF3], lactobacilli [Lactobacillus acidophilus CBT LA1, Lactobacillus rhamnosus CBT LR5], Streptococcus thermophilus CBT ST3) 1 capsule once a day for 1 month. The second group (n = 35) received esomeprazole 20 mg 2 bid, clarithromycin 500 mg 2 bid, amoxicillin 1000 mg 2 bid and bismuth tripotassium dicitrate 240 mg 2 bid for 14 days, probiotic complex (bifidobacteria [Bifidobacterium longum CBT BG7, Bifidobacterium lactis CBT BL3, Bifidobacterium bifidum CBT BF3], lactobacilli [Lactobacillus acidophilus CBT LA1, Lactobacillus rhamnosus CBT LR5], Streptococcus thermophilus CBT ST3) 1 capsule once a day for 1 month. Eradication of H. pylori was assessed using stool antigen test. Results. Eradication rates for the first and second groups in the intent-to-treat (ITT) population were 77.1% and 88.6% (p = 0.205), respectively. In the per-protocol (PP) population, eradication rates were 81.8% and 96.9% (p = 0.051), respectively. Adverse events were reported in 34.3% of patients in the first group and 34.3% of patients in the second group (p = 1). Conclusions. 14-day standard triple therapy boosted with bismuth tripotassium dicitrate and a probiotic complex demonstrates high efficacy and safety profile, and therefore can be recommended as first-line therapy for H. pylori infection in adults.