NCT05483660

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
OTHER	Lactobacillus plantarum	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	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	1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
OTHER	Placebo	Adult milk powder 15 g pertime, three times daily and half an hour before meal.

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2022-08-02
• Last updated: 2022-08-02