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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05483660
• Other study ID #: NFEC-2022-252
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 1, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: July 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: Yang Bai
• Phone: 13925001665
• Email: 13925001665[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

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.
• Bacillus coagulans
1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
• 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.
• Placebo
Adult milk powder 15 g pertime, three times daily and half an hour before meal.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.