AUTHOR=Kiattiweerasak Anya , Aumpan Natsuda , Chonprasertsuk Soonthorn , Pornthisarn Bubpha , Siramolpiwat Sith , Bhanthumkomol Patommatat , Nunanan Pongjarat , Issariyakulkarn Navapan , Mahachai Varocha , Yamaoka Yoshio , Vilaichone Ratha-korn 

TITLE=Efficacy and safety of Lacticaseibacillus rhamnosus R0011 and Lactobacillus helveticus R0052 as an adjuvant for Helicobacter pylori eradication: a double-blind, randomized, placebo-controlled study

JOURNAL=Frontiers in Gastroenterology

VOLUME=2

YEAR=2023

URL=https://www.frontiersin.org/journals/gastroenterology/articles/10.3389/fgstr.2023.1245993

DOI=10.3389/fgstr.2023.1245993

ISSN=2813-1169

ABSTRACT=<sec><title>Background</title><p><italic>Helicobacter pylori</italic> eradication is recommended as a way of providing symptomatic relief for dyspepsia. The limited efficacy of triple therapy is a major problem in many countries, including Thailand. Some probiotics have been shown to improve the <italic>H. pylori</italic> eradication rate and reduce side effects. This study aimed at evaluating the efficacy of probiotic (Lacidofil<sup>®</sup> STRONG) as adjuvant to standard triple therapy.</p></sec><sec><title>Methods</title><p>This randomized, double-blind, placebo-controlled study was conducted between July 2020 and June 2022. Eligible patients with <italic>H. pylori</italic> gastritis (i.e., <italic>n</italic>=90 out of the 160 patients screened) were randomized to receive 14-day standard triple therapy either with probiotics or with a placebo (N=45/group). The treatment regimen entailed 30 mg lansoprazole administered twice daily, 1,000 mg amoxicillin administered twice daily, and 1 g clarithromycin modified-release formulation administered once daily. A probiotic capsule containing <italic>Lacticaseibacillus rhamnosus</italic> R0011 <italic>and Lactobacillus helveticus</italic> R0052 (Lacidofil<sup>®</sup> STRONG) or placebo were given twice daily during the eradication therapy and for an additional 4 weeks. Successful <italic>H. pylori</italic> eradication was defined as a negative <sup>13</sup>C-urea breath test at least 4 weeks after complete eradication.</p></sec><sec><title>Results</title><p>As per-protocol analysis, eradication rates after the 14-day regimen with probiotic or placebo were 90.9% and 75.0% (<italic>p</italic>=0.047), respectively. Antibiotic susceptibility testing demonstrated high clarithromycin resistance (24%). For clarithromycin-resistant strains, there was no statistical difference in eradication rates between the probiotic and placebo groups. Furthermore, probiotic supplementation significantly reduced treatment side effects, including bloating (OR 0.27 [95% CI 0.10 to 0.75], <italic>p</italic>=0.012), diarrhea (OR 0.23 [95% CI 0.28 to 0.65], <italic>p</italic>=0.006), nausea (OR 0.05 [95% CI 0.01 to 0.36], <italic>p</italic>=0.003), and bitter taste (OR 0.14 [95% CI 0.03 to 0.69], <italic>p</italic>=0.015). In addition, the probiotic group had lower gastrointestinal symptom rating scale (GSRS) scores (1.46 ± 0.36 vs. 2.65 ± 0.66, <italic>p</italic>&lt;0.001) and higher SF-36 health-related quality-of-life scores (63.3 ± 10.2 vs. 57.3 ± 13.4, <italic>p</italic>=0.020) after treatment than the placebo group.</p></sec><sec><title>Conclusion</title><p>The probiotic adjuvant with 14-day standard triple therapy improved the <italic>H. pylori</italic> eradication rate. Supplementation with Lacidofil<sup>®</sup> STRONG during the 2-week eradication treatment and 4-week follow-up phase can help to reduce the gastrointestinal side effects of eradication therapy and increase patients’ general health-related quality of life.</p></sec>