The Effect of L. Reuteri (ProGastria) on the Eradication Rate in Elderly Patients Infected with H. Pylori: a Randomized, Double-Blinded, Placebo Controlled Trial

Abstract

Background: Current guidelines recommend first line triple treatment with PPI-clarithromycin and amoxicillin or metronidazole with efficacy of these regimes approaching 70%. Adding a probiotic is a possible means to increase the eradication rate. Aim: To determine whether treatment with L. reuteri ProGastria+PPI is effective in eradicating H. pylori alone or facilitating subsequent eradication. Methods: A randomized, double-blind, placebo-controlled clinical trial performed in a tertiary care setting. A total of 55 patients with dyspeptic symptoms were tested for H. pylori infection by 13C-UBT, stool antigen test, histology and rapid urease test and randomly allocated to omeprazole (2 × 20 mg/day)+placebo or probiotic for 28 days. Afterwards a stool antigen test was performed and if positive a sequential regimen was prescribed. At the end UBT and stool antigen test were performed. A gastrointestinal symptom rating score was completed at baseline, Day 14, 28 and 90. Results: At the end of treatment 57.7% of the patients from the probiotic group and 62.1% from the placebo group had positive stool antigen test (p=0.75, Pearson`s correlation test). Twenty patients were prescribed sequential therapy. Unsuccessful eradication was present in 27.2% from the probiotic group versus 55.6% from the placebo (p=0.36, Fisher`s exact test). A trend towards a lower mean symptom score for the patients treated with probiotic was noted (p>0.05). Conclusion: Although the lacking an ability of ProGastria to eradicate H. pylori, the study showed a trend towards a higher rate of successful eradication if sequential regimen was preceded by a 28-day probiotic treatment.