Efficacy and safety of postbiotic containing inactivated Lactobacillus reuteri (Limosilactobacillus reuteri) DSM 17648 as adjuvant therapy for Helicobacter pylori eradication in adults with functional dyspepsia: A randomized double-blind placebo-contolled trial.

ABSTRACT

INTRODUCTION: Increasing the effectiveness of eradication therapy is an important task in gastroenterology. The aim was to evaluate the efficacy and safety of postbiotic containing inactivated (non-viable) Limosilactobacillus reuteri DSM17648 (Pylopass) as adjuvant treatment for Helicobacter pylori eradication in patients with functional dyspepsia (FD). METHODS: This randomized, double-blind, placebo-controlled, multicenter, parallel study included Helicobacter pylori positive patients with FD. The postbiotic group received Pylopass 200 mg bid for 14 days in combination with eradication therapy (esomeprazole 20 mg bid + amoxicillin 1000 mg bid + clarithromycin 500 mg bid for 14 days) and another 14 days after completion of eradication therapy. The study was registered in the ISRCTN registry (ISRCTN20716052). RESULTS: Eradication efficiency was 96.7% for the postbiotic group versus 86.0% for the placebo group (P=0.039). Both groups showed significant improvements in quality of life and reduction of most gastrointestinal symptoms with no significant differences between groups. The overall number of digestive adverse effects in the postbiotic group was lower than in the placebo group. Serious adverse effects were not registered. CONCLUSIONS: The postbiotic containing inactivated L. reuteri DSM17648 significantly improves the effectiveness of H. pylori eradication therapy in FD and decreases overall number of digestive adverse effects of this therapy.