Efficacy and safety of probiotics combined with bismuth-containing quadruple therapy for Helicobacter pylori eradication: a systematic review and meta-analysis
Open accessAbstract
Objective: Helicobacter pylori ( H. pylori ) infection represents a global health challenge. This study aimed to evaluate the effect of probiotic supplementation on the efficacy and safety of bismuth-containing quadruple therapy (BQT) for H. pylori eradication. Methods: Randomized controlled trials (RCTs) meeting the eligibility criteria were identified through systematic searches of five databases, including PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov . Meta-analyses were conducted using Review Manager software with a random-effects model to calculate pooled relative risks (RR) and 95% confidence intervals (CI). The potential publication bias was evaluated qualitatively, and the certainty of the evidence was subsequently assessed. Results: In total, 10 RCTs involving 1,630 patients were included in the analysis. The results demonstrated that, compared with the BQT group, the H. pylori eradication rate was significantly higher in the probiotics combined with the BQT group (RR 1.06, 95% CI 1.01–1.11, p = 0.009, ARR = 7.5%, NNT ≈ 13). Additionally, the combined therapy significantly reduced the adverse event rate (RR 0.58, 95% CI 0.42–0.80, p = 0.001, ARR = 11.1%, NNT ≈ 9), diarrhea (RR 0.48, 95% CI 0.32–0.73, p = 0.0007, ARR = 0.7%, NNT ≈ 142), and constipation (RR 0.53, 95% CI 0.29–0.94, p = 0.04, ARR = 2.5%, NNT ≈ 40). However, no statistically significant differences were observed for other specific adverse events, including nausea, vomiting, anorexia, heartburn, belching, taste disturbance, abdominal pain, and abdominal bloating. Sensitivity analyses confirmed the robustness of the results for the H. pylori eradication rate and adverse event rate. Conclusion: Combining probiotics with BQT significantly increases the H. pylori eradication rate and reduces adverse events, particularly diarrhea and constipation. These findings support the role of probiotics as a supplementary strategy to enhance both the efficacy and safety of H. pylori eradication therapy. However, the overall certainty of the evidence is low to very low, and the optimal probiotic protocol has yet to be determined, highlighting the need for further high-quality research. Systematic review registration: https://www.crd.york.ac.uk/PROSPERO/view/CRD420251060806 , Identifier CRD420251060806.
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In 10 randomized controlled trials (1630 patients) on bismuth-containing quadruple therapy for Helicobacter pylori, probiotics lowered adverse events from 27.98% in controls to 16.85%.
“In 10 randomized controlled trials (1630 patients) on bismuth-containing quadruple therapy for Helicobacter pylori, probiotics lowered AEs from 27.98% (controls) to 16.85% [112].”
From Current Concepts in Probiotic Safety and Efficacy (2026) · cites this paper as [112]
The Abstract Results report 10 RCTs with 1,630 patients overall. The Results > Meta-analysis section reports the stated adverse-event rates—27.98% with BQT alone and 16.85% with probiotics plus BQT—but says that analysis used only 8 RCTs and 1,434 patients, not all 10 trials and 1,630 patients. (LLM, conf=0.94)
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Current Concepts in Probiotic Safety and Efficacy
Churin, A. A., Sokolyanskaya, L. O., Lukina, A. P., & Karnachuk, O. V. (2026) · Nutrients · doi:10.3390/nu18040696 · Cited by 31 · see citing works
“In 10 randomized controlled trials (1630 patients) on bismuth-containing quadruple therapy for Helicobacter pylori, probiotics lowered AEs from 27.98% (controls) to 16.85% [112].”
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- Authors
- Zhou, S., Yu, Y., Tian, J., Wang, X., Zeng, M., & Song, H.
- Affiliations
- Hunan University of Traditional Chinese Medicine (CN)
- Corresponding author
- Zeng, Meiyan
- Song, Houpan
- Venue
- Frontiers in Microbiology
- Publisher
- Frontiers Media SA
- Published
- 2026-01-07
- Volume
- 16
- Pages
- 1704508-1704508
- ISSN
- 1664-302X (ISSN-L)
- PMC
- PMC12819727
- OpenAlex
- W7119037766
- Cited by
- 2
- References
- 75
- Citations by year
- 2026: 2
- FWCI
- 3.88
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Frontiers in Microbiology (publishedVersion, cc-by)
- PubMed (publishedVersion)
- PubMed Central (publishedVersion, cc-by)
- Funders
- National Natural Science Foundation of China (82374429)
- Topics
- Health Sciences › Medicine › Surgery › Helicobacter pylori-related gastroenterology studies
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Keywords
- Helicobacter pylori, probiotics, bismuth quadruple therapy, Helicobacter pylori eradication, combination therapy, adverse events, diarrhea, constipation, treatment efficacy, treatment safety
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