Probiotics Prescribed With Helicobacter pylori Eradication Therapy in Europe: Usage Pattern, Effectiveness, and Safety. Results From the European Registry on Helicobacter pylori Management (Hp-EuReg)

Abstract

Introduction: To evaluate the prescription patterns, effectiveness, and safety of adding probiotics to Helicobacter pylori eradication therapy, in Europe.

Methods: International, prospective, noninterventional registry of the clinical practice of the European gastroenterologists. Data were collected and quality reviewed until March 2021 at AEG-REDCap. The effectiveness was evaluated by modified intention-to-treat analysis, differentiating by geographic areas. Adverse events (AEs) were categorized as mild, moderate, and severe.

Results: Overall, 36,699 treatments were recorded, where 8,233 (22%) were prescribed with probiotics. Probiotics use was associated with higher effectiveness in the overall analysis (odds ratio [OR] 1.631, 95% confidence interval [CI] 1.456-1.828), as well as in triple (OR 1.702, 95% CI 1.403-2.065), quadruple (OR 1.383, 95% CI 0.996-1.920), bismuth quadruple (OR 1.248, 95% CI 1.003-1.554), and sequential therapies (OR 3.690, 95% CI 2.686-5.069). Lactobacillus genus was associated with a higher therapy effectiveness in Eastern Europe when triple (OR 2.625, 95% CI 1.911-3.606) and bismuth quadruple (OR 1.587, 95% CI 1.117-2.254) first-line therapies were prescribed. In Central Europe, the use of probiotics was associated with a decrease in both the overall incidence of AEs (OR 0.656, 95% CI 0.516-0.888) and severe AEs (OR 0.312, 95% CI 0.217-0.449). Bifidobacterium genus was associated with lower overall (OR 0.725, 95% CI 0.592-0.888) and severe (OR 0.254, 95% CI 0.185-0.347) AEs, and Saccharomyces was associated with reduced overall (OR 0.54, 95% CI 0.32-0.91) and severe (OR 0.257, 95% CI 0.123-0.536) AEs under quadruple-bismuth regimen.

Discussion: In Europe, the use of probiotics was associated with higher effectiveness and safety of H. pylori eradication therapy. Lactobacillus improved treatment effectiveness, whereas Bifidobacterium and Saccharomyces were associated with a better safety profile.

Trial registration: ClinicalTrials.gov NCT02328131.

Keywords: effectiveness; eradication therapy; probiotics; safety.