Efficacy and Safety of Postbiotic (Metabiotic) Contained Inactivated Lactobacillus reuteri (Limosilactobacillus Reuteri) DSM 17648 as Adjuvant Therapy in the Eradication of Helicobacter pylori in Adults with Functional Dyspepsia: A Randomized Double-

Vladimir Ivashkin; Igor Maev; Elena Poluektova; Alexander Sinitsa; Elena Avalueva; Marina Mnatsakanyan; Vladimir Simanenkov; Julia Karpeeva; Daria Kopylova; Irina Kuprina; Yury Kucheryavyy; Tatiana Lapina; Olga Solovyeva; Malle Soom; Natalia Cheremushkina; Evgeniya Maevskaya; Caterina Holz; Roman Maslennikov

doi:10.20944/preprints202312.0836.v1

Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Version 1 : Received: 11 December 2023 / Approved: 12 December 2023 / Online: 12 December 2023 (08:26:54 CET)

Increasing the effectiveness of eradication therapy is an important task of gastroenterology. The aim was to evaluate the efficacy and safety of postbiotic (metabiotic) contained inactivated Limosilactobacillus reuteri DSM 17648 (Pylopass™; Helinorm™) as adjuvant treatment for Helicobacter pylori eradication in patients with functional dyspepsia (FD). This randomized, double-blind, placebo-controlled, multicenter, parallel study included H. pylori positive patients with FD. The postbiotic group received Pylopass 200 mg bid for 14 days in combination with the 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 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. The postbiotic (metabiotic) contained inactivated L. reuteri DSM 17648 significantly improves the effectiveness of H. pylori eradication therapy in FD and decreases overall number of digestive adverse effects of this therapy.

postbiotics; metabiotics; eradication; functional digestive disease; probiotics; microbiota.

Medicine and Pharmacology, Gastroenterology and Hepatology

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Efficacy and Safety of Postbiotic (Metabiotic) Contained Inactivated Lactobacillus reuteri (Limosilactobacillus Reuteri) DSM 17648 as Adjuvant Therapy in the Eradication of Helicobacter pylori in Adults with Functional Dyspepsia: A Randomized Double-

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