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Randomized Controlled Trial
. 2024 Sep 1;15(9):e1.
doi: 10.14309/ctg.0000000000000750.

Efficacy and Safety of Postbiotic 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-Blind Placebo-Controlled Trial

Vladimir Ivashkin  1 , Igor Maev  2 , Elena Poluektova  1   3 , Alexander Sinitsa  4 , Elena Avalueva  5 , Marina Mnatsakanyan  1 , Vladimir Simanenkov  6 , Julia Karpeeva  5 , Daria Kopylova  7 , Irina Kuprina  1 , Yury Kucheryavyy  8 , Tatiana Lapina  1 , Olga Solovyeva  6 , Malle Soom  9 , Natalia Cheremushkina  2 , Evgeniya Maevskaya  2 , Roman Maslennikov  1
Affiliations
Randomized Controlled Trial

Efficacy and Safety of Postbiotic 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-Blind Placebo-Controlled Trial

Vladimir Ivashkin et al. Clin Transl Gastroenterol. .

Abstract

Introduction: Increasing the effectiveness of eradication therapy is an important task in gastroenterology. The aim of this study was to evaluate the efficacy and safety of postbiotic containing inactivated (nonviable) Limosilactobacillus (Lactobacillus) reuteri DSM 17648 (Pylopass) as adjuvant treatment of Helicobacter pylori eradication in patients with functional dyspepsia (FD).

Methods: 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 eradication therapy (esomeprazole 20 mg bid + amoxicillin 1,000 mg bid + clarithromycin 500 mg bid for 14 days) and another 14 days after the completion of eradication therapy. The study was registered in the ISRCTN registry (ISRCTN20716052).

Results: Eradication efficiency was 96.7% for the postbiotic group vs 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.

Discussion: The postbiotic containing 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.

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Conflict of interest statement

Guarantor of the article: Roman Maslennikov, PhD.

Specific author contributions: V.I.: Research idea. V.I., I.M., E.P., and A.S.: Study design. All authors: Research and data analysis. R.M.: Draft writing. All authors: Draft editing.

Financial support: The study was sponsored by Novozymes A/S (Denmark) and Parusin (Germany). The sponsors had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Potential competing interests: The study was sponsored by Novozymes A/S (Denmark) and Parusin (Germany). The sponsors had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Figures

Figure 1.
Figure 1.
CONSORT 2010 flow diagram. H.p., Helicobacter pylori.
See this image and copyright information in PMC

References

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