A Clinical Trial on the Efficacy of Gastric Probiotics in the Treatment of Helicobacter Pylori Infection

Phase 2

Not yet recruiting

• Conditions: Helicobacter Pylori Infection
• Interventions: Other: Bacillus coagulans; Other: Placebo; Other: Lactobacillus plantarum + Bacillus coagulans; Other: Lactobacillus plantarum

• Registration Number: NCT05483660
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

The purpose of this study is to assess the safety and efficacy of Lactobacillus plantarum, Bacillus coagulans and Lactobacillus plantarum + Bacillus coagulans for eradication of Helicobacter Pylori, as well as the efficacy of Lactobacillus plantarum and Bacillus coagulans on side-effect caused by Helicobacter Pylori.

Detailed Description

All patients included in this randomized controlled clinical trial will be selected according to strict inclusion and exclusion criteria. At the same time, the benefits and risks of participating in this trial will be explained to the patients before the start of the study, the patients' right to informed consent will be respected, and the informed consent will be signed. After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner (participants and investigator) in a 1:1:1:1 ratio to Lactobacillus plantarum (1.5×10\^10 per time, three times daily) or Bacillus coagulans (1.5×10\^10 per time, three times daily) or Lactobacillus plantarum + Bacillus coagulans (1.5×10\^10 per time, three times daily) or placebo ( 15g per time, three times daily). At the same time, volunteers will be recruited from healthy people to perform the same treatment.

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-24
• Study First Submitted QC: 2022-07-29
• Last Update Submitted: 2022-07-29
• Study Start: 2022-08-01
• Study First Posted: 2022-08-02
• Last Update Posted: 2022-08-02
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Aged 18-75 years.
• Diagnosed by 13C-UBT within 2 weeks before entry.

Exclusion Criteria

• Previous treatment for H. pylori infection.
• Administration of antibiotics, probiotics/prebiotics, PPIs, H2 receptor antagonists, bismuth preparations, laxatives, anti-diarrhoeals, and certain antimicrobial traditional Chinese medicines 4 weeks before.
• Previous history of gastrointestinal surgery.
• Severe or unstable diseases.
• Pregnancy or lactation.
• Alcoholics and drug abusers.
• Staff of this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bacillus coagulans	Bacillus coagulans	1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
Placebo	Placebo	Adult milk powder 15 g per time, three times daily and half an hour before meal.
Lactobacillus plantarum + Bacillus coagulans	Lactobacillus plantarum + Bacillus coagulans	1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
Lactobacillus plantarum	Lactobacillus plantarum	1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.

Primary Outcome Measures

Name	Time	Method
Eradication of Helicobacter pylori	The eighth week of the trial	All participants will have a 13C-urea breath test to see if their 13C value falls below the threshold for H. pylori eradication.

Secondary Outcome Measures

Name	Time	Method
The condition of gastrointestinal symptoms in the third week	The third week of the trial.	We will use Gastrointestinal symptoms rating scale (GSRS) to know about the level of their gastrointestinal symptoms after they receive the probiotic or placebo after three weeks.
The condition of gastrointestinal symptoms before the trial	Baseline	We will use Gastrointestinal symptoms rating scale (GSRS) to know about the baseline level of their gastrointestinal symptoms before they receive the probiotic or placebo.
The condition of gastrointestinal symptoms in the second week	The second week of the trial.	We will use Gastrointestinal symptoms rating scale (GSRS) to know about the level of their gastrointestinal symptoms after they receive the probiotic or placebo after two weeks.
The condition of gastrointestinal symptoms in the fourth week	The fourth week of the trial.	We will use Gastrointestinal symptoms rating scale (GSRS) to know about the level of their gastrointestinal symptoms at the fourth week of this trial.
The condition of gastrointestinal symptoms in the first week	The first week of the trial.	We will use Gastrointestinal symptoms rating scale (GSRS) to know about the level of their gastrointestinal symptoms after they receive the probiotic or placebo already a week.