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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
300
1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
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.
Time frame: The eighth week of the trial
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Adult milk powder 15 g pertime, three times daily and half an hour before meal.
Time frame: The fourth week of the trial.