Multistrain probiotics alleviate gastrointestinal symptoms during bismuth quadruple therapy for Helicobacter pylori infection

doi:10.3748/wjg.v31.i42.112577

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Nov 14, 2025 (publication date) through Mar 5, 2026

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World Journal of Gastroenterology

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1007-9327

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Randomized Controlled Trial

World J Gastroenterol. Nov 14, 2025; 31(42): 112577
Published online Nov 14, 2025. doi: 10.3748/wjg.v31.i42.112577

Multistrain probiotics alleviate gastrointestinal symptoms during bismuth quadruple therapy for Helicobacter pylori infection

Wen-Jun Liu, Yue-Ming Zhao, Qing-Qing Xie, Min-Chan Wu, Yun-Feng Pan, Hao-Kun Yan, Xiao-Xi Shan, Wen-Ting Xu, Yang-Ling Liu, Cai-Xia Peng, Xiao-Mei Zhang, Qian Lin

Wen-Jun Liu, Qing-Qing Xie, Min-Chan Wu, Yun-Feng Pan, Xiao-Xi Shan, Wen-Ting Xu, Yang-Ling Liu, Cai-Xia Peng, Qian Lin, Department of Nutrition Science and Food Hygiene, Xiangya School of Public Health, Central South University, Changsha 410078, Hunan Province, China

Yue-Ming Zhao, Hao-Kun Yan, Jin Qiao Biotech Co., Ltd., Huai’an 223001, Jiangsu Province, China

Xiao-Mei Zhang, Department of Gastroenterology, Xiangya Hospital, Central South University, Changsha 410008, Hunan Province, China

Xiao-Mei Zhang, National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha 410007, Hunan Province, China

Co-first authors: Wen-Jun Liu and Yue-Ming Zhao.

Co-corresponding authors: Xiao-Mei Zhang and Qian Lin.

Author contributions: Lin Q, Liu WJ and Xie QQ conceived and designed the study; Liu WJ and Xie QQ developed the methodology; Zhao YM and Yan HK developed the probiotic product; Liu WJ and Xie QQ performed software tasks; Liu WJ, Xie QQ and Lin Q validated the study; Liu WJ conducted formal analysis; Liu WJ, Xie QQ, Wu MC, Pan YF, Shan XX, Xu WT, Liu YL and Peng CX performed investigation; Lin Q provided resources; Liu WJ curated data; Liu WJ wrote the original draft; Lin Q reviewed and edited the manuscript; Liu WJ prepared visualization; Lin Q and Zhang XM supervised the study; Lin Q, Xie QQ administered the project; Lin Q acquired funding. Liu WJ and Zhao YM are designated as co-first authors. Liu WJ co-conceived and co-designed the study, co-developed the methodology, performed all software tasks and formal data analysis, curated the data, produced the original draft, and participated in extensive experimental investigation. Zhao YM co-developed the probiotic product used in this study, provided essential technical expertise for its characterization and validation, and substantially contributed to data acquisition and interpretation. The intellectual contributions of both authors are of equal substance and significance. Lin Q and Zhang XM are co-corresponding authors. Lin Q oversaw the overall study design, secured funding, provided critical resources, supervised the project, administered the project, and took primary responsibility for manuscript review, editing, and communication with the journal during submission, peer-review, and publication. Zhang XM co-supervised the study and provided strategic guidance.

Supported by the Hyproca Nutrition Co., Ltd.

Institutional review board statement: The study was reviewed and approved by the Ethics Committee of Xiangya Hospital, Central South University (Approval No. Ke202207156), and the Xiangya School of Public Health, Central South University (Approval No. XYGW-2021-105).

Clinical trial registration statement: This study is registered at the China Clinical Trial Registry (https://www.chictr.org.cn/). The registration identification number is ChiCTR2200056446.

Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.

Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.

CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.

Data sharing statement: The data supporting the findings of this study are not publicly available, as they contain information that could compromise participants' privacy. However, the data are available from the corresponding author at linqian@csu.edu.cn upon reasonable request.

Corresponding author: Qian Lin, MD, PhD, Professor, Department of Nutrition Science and Food Hygiene, Xiangya School of Public Health, Central South University, No. 172 Tongzipo Road, Yuelu District, Changsha 410078, Hunan Province, China. linqian@csu.edu.cn

Received: July 31, 2025
Revised: September 4, 2025
Accepted: October 13, 2025
Published online: November 14, 2025
Processing time: 105 Days and 17.6 Hours

Abstract

BACKGROUND

Bismuth quadruple therapy (BQT) induces troublesome gastrointestinal side effects that reduce adherence and efficacy.

AIM

To evaluate multistrain probiotics efficacy for alleviating gastrointestinal symptoms during BQT for Helicobacter pylori (H. pylori) eradication.

METHODS

One hundred seventy-four adults (18-60 years) with confirmed H. pylori infections between July 2022 and December 2023 were randomised to receive BQT plus a multispecies probiotic (n = 89) or a maltodextrin placebo (n = 85) for 4 weeks. Gastrointestinal Symptom Rating Scale (GSRS) and Bristol Stool Classification Scale scores were collected at baseline, 2, 4 and 8 weeks; eradication was assessed 8 weeks post-treatment. Intention-to-treat analysis used multiple imputation and SPSS 26.0.

RESULTS

After 8 weeks, GSRS scores (all dimensions and total) decreased significantly compared with those at baseline. ITT analysis showed significantly greater reductions for the intervention vs the placebo in reflux by week 2, total/diarrhea scores by week 4, and total/dyspepsia scores by week 8. Probiotics provided no protective effect against gastrointestinal symptoms at week 2 but showed significant protection at weeks 4 and 8. Both groups reported decreased diarrhea/constipation-type stools and increased normal-type stools post-intervention. H. pylori eradication rates were slightly higher for the intervention group (88.8%) than for the placebo group (84.7%), but the difference was not significant (P = 0.430).

CONCLUSION

Multistrain probiotics significantly relieved BQT-associated gastrointestinal symptoms without affecting eradication success.

Keywords: Helicobacter pylori infection; Bismuth quadruple therapy; Multistrain probiotics; Gastrointestinal symptoms; Randomised controlled trial

Core Tip: In this randomized, double-blind, placebo-controlled trial involving 174 adults, a 4-week multistrain probiotics formula mainly containing five Bifidobacterium and Lactobacillus species added to bismuth quadruple therapy for Helicobacter pylori infection significantly reduced reflux, dyspepsia and diarrhea scores at weeks 4-8 without affecting eradication rates. Probiotics are a safe adjunct to ease antibiotic-associated gastrointestinal symptoms.