Clinical trial NCT05483660: A Clinical Trial on the Efficacy of Gastric Probiotics in the Treatment of Helicobacter Pylori Infection
Official title: A Randomized, Controlled, Double-blind Trial on the Efficacy of Gastric Probiotics in the Treatment of Helicobacter Pylori Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Helicobacter Pylori Infection
Keywords: Gastric Probiotics
Side-effect
Eradication rate
Helicobacter pylori
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Eradication of Helicobacter pylori
timeFrame: The eighth week of the trial
Secondary outcomes:
measure: The condition of gastrointestinal symptoms before the trial
timeFrame: Baseline
measure: The condition of gastrointestinal symptoms in the first week
timeFrame: The first week of the trial.
measure: The condition of gastrointestinal symptoms in the second week
timeFrame: The second week of the trial.
measure: The condition of gastrointestinal symptoms in the third week
timeFrame: The third week of the trial.
measure: The condition of gastrointestinal symptoms in the fourth week
timeFrame: The fourth week of the trial.
Other outcomes:
Locations:
Study officials:
References: