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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Controlled, Double-blind Trial on the Efficacy of Gastric Probiotics in the Treatment of Helicobacter Pylori Infection

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Other: Lactobacillus plantarum
* Other: Bacillus coagulans
* Other: Lactobacillus plantarum + Bacillus coagulans
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus plantarum<br>1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal. | Other: Lactobacillus plantarum<br>* 1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.<br>|
| Experimental: Bacillus coagulans<br>1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal. | Other: Bacillus coagulans<br>* 1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.<br>|
| Experimental: Lactobacillus plantarum + Bacillus coagulans<br>1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal. | Other: Lactobacillus plantarum + Bacillus coagulans<br>* 1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.<br>|
| Placebo Comparator: Placebo<br>Adult milk powder 15 g per time, three times daily and half an hour before meal. | Other: Placebo<br>* Adult milk powder 15 g pertime, three times daily and half an hour before meal.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The condition of gastrointestinal symptoms before the trial | 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. | Baseline | 
| The condition of gastrointestinal symptoms in the first week | 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. | The first week of the trial. | 
| The condition of gastrointestinal symptoms in the second week | 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 second week of the trial. | 
| The condition of gastrointestinal symptoms in the third week | 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 third week of the trial. | 
| The condition of gastrointestinal symptoms in the fourth week | 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 fourth week of the trial. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric Probiotics, Side-effect, Eradication rate, Helicobacter pylori