The Ameliorating Effect of Lactobacillus gasseri OLL2716 on Functional Dyspepsia in Helicobacter pylori -Uninfected Individuals: A Randomized Controlled Study

Abstract

Probiotics appear to improve Helicobacter pylori -associated dyspepsia via an inhibitory effect on H. pylori; however, uncertainty exists regarding their effects in H. pylori -uninfected individuals. We evaluated the efficacy of Lactobacillus gasseri OLL2716 ( L. gasseri OLL2716) on H. pylori -uninfected individuals with functional dyspepsia (FD). Methods: A double-blind, parallel-group, placebo-controlled, randomized, controlled trial was performed. Participants were randomly assigned to ingest L. gasseri OLL2716- containing yogurt ( L. gasseri OLL2716 group) or L. gasseri OLL2716-free yogurt (placebo group) for 12 weeks. Participants completed questionnaires that dealt with a global assessment as well as symptom severity. The per-protocol (PP) population was evaluated for efficacy in accordance with a plan prepared beforehand. Results: Randomization was performed on 116 individuals; the PP population consisted of 106 individuals (mean age 42.8 ± 9.0). The impressions regarding the overall effect on gastric symptoms were more positive in the L. gasseri OLL2716 group compared to that in the placebo group (statistical trend; p = 0.073). The elimination rate for major FD symptoms was 17.3 and 35.3% in the placebo and L. gasseri OLL2716 groups respectively ( p = 0.048). Conclusion: L. gasseri OLL2716 has beneficial effects on FD without H. pylori involvement.