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).

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.