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

Nanfang Hospital, Southern Medical University

Status and phase: Not yet enrolling; Phase 2

Conditions: Helicobacter Pylori Infection

Treatments: Other: Lactobacillus plantarum; Other: Lactobacillus plantarum + Bacillus coagulans; Other: Bacillus coagulans; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05483660

NFEC-2022-252

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 4 patient groups, including a placebo group

Lactobacillus plantarum

Experimental group

Description:

1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.

Treatment:

Other: Lactobacillus plantarum

Bacillus coagulans

Experimental group

Description:

1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.

Treatment:

Other: Bacillus coagulans

Lactobacillus plantarum + Bacillus coagulans

Experimental group

Description:

1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.

Treatment:

Other: Lactobacillus plantarum + Bacillus coagulans

Placebo

Placebo Comparator group

Description:

Adult milk powder 15 g per time, three times daily and half an hour before meal.

Treatment:

Other: Placebo