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The efficacy and safety of Clostridium butyricum and Bacillus coagulans in Helicobacter pylori eradication treatment: An open-label, single-arm pilot study.

ABSTRACT: BACKGROUND:Helicobacter pylori (H pylori) infection plays a critical role in gastritis-associated diseases, gastroduodenal ulcers, and even gastric cancer. Studies have shown that probiotics may exhibit antagonistic activity against H pylori. METHODS:This study aimed to assess the efficacy and safety of monotherapy with Clostridium butyricum (C butyricum) and Bacillus coagulans (B coagulans) for H pylori treatment. Our research was an open-label, single-arm pilot study of H pylori eradication. Subjects diagnosed with H pylori infection as outpatients at Xijing Hospital were randomized (1:1:1) to receive 8 weeks of therapy with C butyricum (group A), B coagulans (group B), or C butyricum plus B coagulans (group?C). H pylori status was assessed 1 to 2 weeks after treatment. The H pylori eradication rate according to intention-to-treat and per-protocol analyses was the primary outcome of study, and the delta over baseline score, adverse events, and compliance were the secondary outcomes. This study was registered at ClinicalTrials.gov (NCT03857425). RESULTS:A total of 150 subjects were consecutively enrolled from February 2019 to August 2019. The ITT analysis demonstrated that the 3 groups achieved similar eradication rates (18%, 20%, and 26%, respectively, P?=?.597). The PP analysis yielded a similar result (24.3%, 26.3%, and 32.5%, respectively, P?=?.703). None of the subjects reported adverse events during treatment. The 3 groups had comparable compliance rates (74% vs 76% vs 80%, P?>?.05). CONCLUSION:C butyricum and B coagulans may effectively inhibit H pylori to some extent, with rare adverse events, and thus may reduce the burden of antibiotic resistance.

SUBMITTER: Zhang J

PROVIDER: S-EPMC7647598 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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The efficacy and safety of Clostridium butyricum and Bacillus coagulans in Helicobacter pylori eradication treatment: An open-label, single-arm pilot study.

Zhang Jian J Guo Jingzhi J Li Dan D Chen Min M Liu Jie J Feng Chenchen C He Qi Q Zhao Jing J Zhang Luyao L Chen Jie J Shi Yongquan Y

Medicine 20201101 45

<h4>Background</h4>Helicobacter pylori (H pylori) infection plays a critical role in gastritis-associated diseases, gastroduodenal ulcers, and even gastric cancer. Studies have shown that probiotics may exhibit antagonistic activity against H pylori.<h4>Methods</h4>This study aimed to assess the efficacy and safety of monotherapy with Clostridium butyricum (C butyricum) and Bacillus coagulans (B coagulans) for H pylori treatment. Our research was an open-label, single-arm pilot study of H pylori ...[more]

PMID: 33157939

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Project description:BackgroundBismuth quadruple therapy is currently consensus recommendation for first-line Helicobacter pylori (H. pylori) treatment; however, the optimal duration is unknown. We compared the efficacy of 10-day bismuth quadruple therapy with that of 14-day bismuth quadruple therapy for first-line eradication.MethodsFor our multicentre, parallel randomised, open-label, and non-inferiority study, we recruited H. pylori treatment-naïve patients from one medical centre and one teaching hospital in Taiwan. Patients were randomly assigned (1:1) to receive 10-day (PBMT-10) or 14-day (PBMT-14) bismuth quadruple therapy. The primary outcome was the eradication rate as determined by intention-to-treat (ITT) and per-protocol (PP) analyses. The eradication rates between the two groups were compared using a one-sided α value of 0.025 and a non-inferiority margin of 7%. The secondary outcomes were the rate of adverse effects. The trial is registered with ClincialTrials.gov (NCT04527055).FindingsFrom August 3, 2020 to April 28, 2023, 313 H. pylori treatment-naïve patients (PBMT-10 = 157; PBMT-14 = 156) were enrolled. 35 patients were excluded from PP analyses. The eradication rates (95% CI) for PBMT-10 and PBMT-14 were respectively 92.4% (88.2%-96.5%) and 92.9% (88.9%-97.0%) by ITT analyses, and 97.9% (95.5%-100.0%) and 99.3% (97.8%-100.0%) by PP analyses. The eradication rates for PBMT-10 were non-inferior to those for PBMT-14 (absolute difference [lower boundary of the one-sided 97.5% CI] -0.6% [-6.7%], PNI = 0.020 in ITT analyses, -1.4% [-5.8%], PNI = 0.007 in PP analyses). The rates of overall adverse effects (54.1% versus 57.1%, P = 0.604) were similar between the two groups; nevertheless, the rates of dizziness (18.5% versus 34.0%, P = 0.003) and vomiting (4.5% versus 12.8%, P = 0.008) were lower in PBMT-10 than in PBMT-14.InterpretationThe 10-day bismuth quadruple therapy was non-inferior to the 14-day therapy as a first-line treatment for eradicating H. pylori infection and had no different rates of overall adverse effects, but less serious adverse events in terms of dizziness and vomiting.FundingThe National Science and Technology Council and Ministry of Health and Welfare, Taiwan.

Project description:BackgroundHelicobacter pylori (Hp) eradication has been used for many years. Yet, the impact of this eradication on the normal gastric microflora is not well understood. In this study, we explored the effect of eradication on the stomach microbial community and its recovery after successful Hp eradication.MethodsAmong the 89 included patients, 23, 17, 40, and 9 were included in the Hp-negative, Hp-positive, successful eradication, and failed eradication groups, respectively. Four subgroups were further determined according to disease status (Hp-negative chronic gastritis [N-CG], Hp-negative atrophic gastritis [N-AG], successful-eradication chronic gastritis [SE-CG], and atrophic gastritis with successful eradication [SE-AG]). During the endoscopic examination, one piece of gastric mucosa tissue was obtained from the lesser curvature side of the gastric antrum and gastric corpus, respectively. In addition, 16S rDNA gene sequencing was used to analyze the gastric mucosal microbiome.ResultsIn the Hp-negative group, the gastric microbiota was dominated by five phyla: Firmicutes, Proteobacteria, Actinobacteria, Bacteroidetes, and Fusobacteria. After successfully eradicating Hp, the bacterial flora in the stomach recovered to a considerable extent. In the failed eradication group, the flora was similar to the flora in Hp-positive subjects based on the alpha and beta diversities. Among the groups, Curvibacter and Acinetobacter were enriched in the presence of Hp (i.e., failed eradication and Hp-positive groups), suggesting that these two genera could be used as biomarkers in the symbiotic flora in the presence of Hp. SE-CG was characterized by an increase in Firmicutes taxa and a decrease in Proteobacteria taxa compared with N-CG. SE-AG was characterized by a decrease in Firmicutes relative to N-AG. Finally, no differences were found in the pairwise comparisons of nitrate and nitrite reductase functions of the microflora among the four subgroups.ConclusionsAfter Hp infection, the diversity and relative abundance of gastric microflora were significantly decreased. Yet, gastric microbiota could be partially restored to the Hp-negative status after eradication. Still, this effect was incomplete and might contribute to the long-term risks.

Dataset Information

The efficacy and safety of Clostridium butyricum and Bacillus coagulans in Helicobacter pylori eradication treatment: An open-label, single-arm pilot study.

Publications

The efficacy and safety of Clostridium butyricum and Bacillus coagulans in Helicobacter pylori eradication treatment: An open-label, single-arm pilot study.

Similar Datasets

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