Randomized, double-blind, placebo-controlled clinical trial on the usefulness of probiotic Lactobacillus reuteri in bismuth-containing quadruple eradication therapy for infection with Helicobacter pylori.

INTRODUCTION The primary goal of this study was to compare gastrointestinal symptom reduction in patients on bismuth-containing quadruple eradication therapy supplemented with Lactobacillus reuteri strains (DSM 17938 and ATCC PTA 6475) or placebo. MATERIALS AND METHODS This was randomized, double-blind, parallel-arm, placebo-controlled clinical trial. Patients received first-line an eradication regimen based on bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride (three-in-one capsules), and omeprazole 40 mg twice a day for ten days, plus a probiotic or placebo tablet for 30 days. During follow-up gastrointestinal symptoms were assessed using an evaluation scale (GSRS), and adverse events were collected at 0, 14, 28, and 56 days. RESULTS A total of 80 patients were included from February 2018 to May 2019 at a single site. Eradication therapy was effective for 85% of patients, with no differences between treatment arms. In the group receiving the probiotic, abdominal pain decreased in 42% of patients, compared with 19% in the control group (OR: 0.27; CI, 0.13-0.58; p < 0.001), and abdominal distension decreased in 25% versus 17% in the control group (OR: 0.24; IC, 0.19-0.84; p < 0.001); Conclusions: Treatment with L. reuteri only reduced abdominal pain and distension. Further studies are needed to establish the role of probiotics as adjuvant therapy in H. pylori eradication.