Probiotic Supplementation for Treatment of Helicobacter pylori Infection: A Double-Blind Randomized Clinical Trial

Abstract

Background/Aims: The effects of probiotic supplementation on <i>Helicobacter pylori (H. pylori)</i> eradication therapy are not completely understood. In this study, we investigated the effects of continuous probiotic administration on eradication rates, recrudescence, and symptom response following completion of a course of <i>H. pylori</i> therapy.Methods: This prospective, randomized, double-blind placebo-controlled trial was performed between June 2018 and 2020. Twohundred seventy patients who received a standard triple regimen for <i>H. pylori</i> eradication, were included in the study. Participants were randomized to receive a probiotic as adjunctive therapy (<i>Enterococcus faecium</i> 4.5×10<sup>8</sup> and Bacillus subtilis 5.0×10<sup>7</sup>; Medilac-S®, Hanmi Pharmaceuticals, Seoul, Korea) or a placebo (one tablet thrice daily) for 28 days, following <i>H. pylori</i> eradication. Participants who showed successful eradication underwent a repeat <sup>13</sup>C-urea breath test after 6 months.Results: Eradication rates in the probiotic and placebo groups were 77.1% and 72.4%, respectively (<i>P</i>=0.48) using per-protocol analysis. Using intention-to-treat analysis, eradication rates were 67.4% and 65.9%, respectively (<i>P</i>=0.43). Of 149 patients who were followed-up after 6 months, four patients had recrudescence (2.7%). Recrudescence rates did not differ between the probiotic and placebo groups. Of the 76 patients who had non-ulcer dyspepsia, 60 (78.9%) showed symptom resolution after 6 months. This beneficial effect was most pronounced in patients with postprandial distress syndrome (<i>P</i>=0.02).Conclusions: Consecutive probiotic supplementation following <i>H. pylori</i> eradication therapy did not increase eradication rates or decrease recrudescence rates.