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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Other: Lactobacillus plantarum; Other: Bacillus coagulans; Other: Lactobacillus plantarum + Bacillus coagulans; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yang Bai; Phone Number: 13925001665; Email: 13925001665@163.com
• Study Contact Backup: Name: Hongying Fan; Phone Number: 13631381172; Email: biofhy@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: Lactobacillus plantarum; 1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
Experimental: 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: Bacillus coagulans; 1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
Experimental: 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: 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 Comparator: Placebo; Adult milk powder 15 g 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): August 31, 2024
• Study Completion (Anticipated): August 31, 2024

Study Registration Dates

• First Submitted: July 24, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Eradication rate; Gastric Probiotics; Side-effect
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections
• Other Study ID Numbers: NFEC-2022-252

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: The data will be available after August 31, 2025, and will be permanently public.
• IPD Sharing Access Criteria: Everyone
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No