Lactobacillus reuteri strain combination in Helicobacter pylori infection: a randomized, double-blind, placebo-controlled study

Goals: The goals of this study were to investigate the role of a new probiotic preparation (Lactobacillus reuteri DSM 17938 and L. reuteri ATCC PTA 6475) in Helicobacter pylori infection. Background: Specific probiotic strains play a role in H. pylori infection for their ability to decrease bacterial load and gastritis, prevent antibiotic-associated side effects, and increase the eradication rate. Study: This is a prospective, double-blind, randomized, placebocontrolled study in a tertiary care setting. A total of 100 H. pylori– positive naive patients received either L. reuteri combination (2� 108 Colony Forming Units) or placebo during a 3-phase study (pre-eradication, eradication, and follow-up). All underwent 13C urea breath test (13C-UBT), blood assessments of gastrin-17 (G17), endoscopy, and the Gastrointestinal Symptom Rating Scale. Eradication was confirmed by 13C-UBT 8 weeks after the completion of therapy. Results: Fifty patients were allocated in each group. During preeradication period, 13 C-UBT d decreased by 13% in L. reuteri combination as compared with a 4% increase in placebo (� 13.2 ± 34% vs. 4.3 ± 27%; P < 0.03). During eradication, GSRS increased significantly in placebo as compared with L. reuteri combination (6.8 ± 2.9 vs. 4 ± 3.1; P < 0.01). Significantly less patients in L. reuteri combination as compared with placeboreported side effects (40.9% vs. 62.8%; P < 0.04). An abnormal G17 value was found in patients receiving placebo as compared with L. reuteri combination (28% vs. 12%; P < 0.02). Eradication rate was 75% in L. reuteri combination and 65.9% in placebo (P = NS). L. reuteri combination increased eradication rate by 9.1% (odds ratio: 1.5). Conclusions: L. reuteri combination alone is able to exert an inhibitory effect on H. pylori growth, and when administered with eradication therapy, it determines a significant reduction in antibiotic-associated side effects. Moreover, L. reuteri combination was able to decrease serum G17 levels and to (not significantly) increase the H. pylori–eradication rate.