Year 2022 / Volume 114 / Number 2
Original
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

89-95

DOI: 10.17235/reed.2021.7931/2021

Carolina Moreno Márquez, Paula Fernández Álvarez, Teresa Valdés Delgado, Luisa Castro Laria, Federico Argüelles Arias, Ángel Caunedo Álvarez, Blas José Gómez Rodríguez,

Abstract
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 a randomized, double-blind, parallel-arm, placebo-controlled clinical trial. Patients received a first-line 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 in 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.
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Moreno Márquez C, Fernández Álvarez P, Valdés Delgado T, Castro Laria L, Argüelles Arias F, Caunedo Álvarez Á, et all. 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. 7931/2021


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Publication history

Received: 01/03/2021

Accepted: 13/04/2021

Online First: 05/05/2021

Published: 07/02/2022

Article revision time: 38 days

Article Online First time: 65 days

Article editing time: 343 days


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