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Probiotic supplementation with Lactobacillus plantarum and Pediococcus acidilactici for Helicobacter pylori therapy: A randomized, double‐blind, placebo‐controlled trial
Author(s) -
McNicholl Adrian G.,
MolinaInfante Javier,
Lucendo Alfredo J.,
Calleja José Luis,
PérezAisa Ángeles,
Modolell Inés,
Aldeguer Xavier,
Calafat Margalida,
Comino Luis,
Ramas Mercedes,
Callejo Ángel,
Badiola Carlos,
Serra Jordi,
Gisbert Javier P.
Publication year - 2018
Publication title -
helicobacter
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.206
H-Index - 79
eISSN - 1523-5378
pISSN - 1083-4389
DOI - 10.1111/hel.12529
Subject(s) - pediococcus acidilactici , medicine , probiotic , placebo , tolerability , lactobacillus plantarum , helicobacter pylori , concomitant , gastroenterology , randomized controlled trial , adverse effect , biology , bacteria , pathology , lactic acid , genetics , alternative medicine
Objective To evaluate the safety, tolerability and efficacy of a probiotic supplementation for Helicobacter pylori (H. pylori) eradication therapy. Design Consecutive adult naive patients with a diagnosis of H. pylori infection who were prescribed eradication therapy according to clinical practice (10‐day triple or nonbismuth quadruple concomitant therapy) randomly received probiotics (1 × 10 9 colony‐forming units each strain, Lactobacillus plantarum and Pediococcus acidilactici ) or matching placebo. Side effects at the end of the treatment, measured through a modified De Boer Scale, were the primary outcome. Secondary outcomes were compliance with therapy and eradication rates. Results A total of 209 patients (33% triple therapy, 66% non‐bismuth quadruple therapy) were included [placebo (n = 106) or probiotic (n = 103)]. No differences were observed regarding side effects at the end of the treatment between groups (β −0.023, P 0.738). Female gender ( P < 0.001) and quadruple therapy ( P 0.007) were independent predictors of side effects. No differences in compliance were observed, regardless of the study group or eradication therapy. Eradication rates were similar between groups [placebo 95% (95% confidence interval ( CI ), 89% to 98%) vs probiotic 97% (95% CI , 92% to 99%), P 0.721]. There were no relevant differences in cure rates (>90% in all cases) between triple and quadruple concomitant therapy. Conclusion Probiotic supplementation containing Lactobacillus Plantarum and Pediococcus acidilactici to H. pylori treatment neither decreased side effects nor improved compliance with therapy or eradication rates.