Probiotic supplementation improves tolerance to Helicobacter pylori eradication therapy--a placebo-controlled, double-blind randomized pilot study.

BACKGROUND H. pylori is the major cause of chronic gastritis, and a risk factor for peptic ulcer and gastric cancer. AIM To investigate the effect of probiotic supplementation on the tolerance and efficacy of H. pylori eradication treatment in a randomized, double-blind, placebo-controlled trial. METHODS A total of 338 volunteers were screened for H. pylori infection. The eligibility criteria were met by 47 subjects whose H. pylori infection was verified at the outset and re-evaluated after the treatment by the 13C-urea breath test and by enzyme immunoassay serology. The subjects were randomized to receive probiotic therapy (Lactobacillus rhamnosus GG, L. rhamnosusLC705, Bifidobacterium breve Bb99 and Propionibacterium freudenreichii ssp. shermanii JS) or a placebo during H. pylori eradication and for 3 weeks following the treatment, and recorded their daily symptoms in a standardized diary. RESULTS When the frequencies of new or aggravated symptoms were evaluated, no significant differences were found between the two groups for individual symptoms. However, the probiotic group showed less treatment-related symptoms as measured by the total symptom score change (P = 0.038) throughout the H. pylori eradication therapy in contrast to the placebo group. The H. pylori eradication rate was non-significantly higher in the group receiving probiotic therapy (91% vs. 79%, P = 0.42). In this group the recovery of probiotic bacteria in the faeces increased significantly (P < 0.001). CONCLUSIONS In this pilot study, probiotic supplementation did not diminish significantly the frequency of new or aggravated symptoms during H. pylori eradication. However, our data suggest an improved tolerance to the eradication treatment when total symptom severity was taken into account. Furthermore, the results show that probiotic bacteria are able to survive in the gastrointestinal tract despite the intensive antimicrobial therapy.