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

2020-11-06
Medicine 99(45)
- Jian Zhang
- Jingzhi Guo
- Dan Li
- Min Chen
- Jie Liu
- Chenchen Feng
- Qi He
- Jing Zhao
- Luyao Zhang
- Jie Chen
- Yongquan Shi

PubMed: 33157939
DOI: 10.1097/md.0000000000022976

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 150
Population: 150 subjects diagnosed with H pylori infection as outpatients at Xijing Hospital
Methods: open-label, single-arm pilot study; 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)
Blinding: Open-label
Duration: 8 weeks

Large Human Trial

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.

Research Insights

Bacillus coagulans→Increased Helicobacter pylori Eradication Rate
The PP analysis yielded a similar result (24.3%, 26.3%, and 32.5%, respectively, P = .703).
Effect
Neutral
Effect size
Small
Dose
not stated
Bacillus coagulans→Reduced Helicobacter Pylori Infection
The ITT analysis demonstrated that the 3 groups achieved similar eradication rates (18%, 20%, and 26%, respectively, P = .597).
Effect
Neutral
Effect size
Small
Dose
not stated
Clostridium butyricum→Increased Helicobacter pylori Eradication Rate
The PP analysis yielded a similar result (24.3%, 26.3%, and 32.5%, respectively, P = .703).
Effect
Neutral
Effect size
Small
Dose
not stated
Clostridium butyricum→Reduced Helicobacter Pylori Infection
The ITT analysis demonstrated that the 3 groups achieved similar eradication rates (18%, 20%, and 26%, respectively, P = .597).
Effect
Neutral
Effect size
Small
Dose
not stated

Adverse Events Reported

Bacillus coagulans→Overall tolerability
None of the subjects reported adverse events during treatment.
Finding
Reported
Clostridium butyricum→Overall tolerability
None of the subjects reported adverse events during treatment.
Finding
Reported