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
1 other identifier
interventional
300
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedFirst Posted
Study publicly available on registry
August 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedAugust 2, 2022
July 1, 2022
2.1 years
July 24, 2022
July 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
The condition of gastrointestinal symptoms before the trial
Baseline
The condition of gastrointestinal symptoms in the first week
The first week of the trial.
The condition of gastrointestinal symptoms in the second week
The second week of the trial.
The condition of gastrointestinal symptoms in the third week
The third week of the trial.
The condition of gastrointestinal symptoms in the fourth week
The fourth week of the trial.
Study Arms (4)
Lactobacillus plantarum
EXPERIMENTAL1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
Bacillus coagulans
EXPERIMENTAL1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
Lactobacillus plantarum + Bacillus coagulans
EXPERIMENTAL1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
Placebo
PLACEBO COMPARATORAdult milk powder 15 g per time, three times daily and half an hour before meal.
Interventions
1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
Eligibility Criteria
You may qualify if:
- Aged 18-75 years.
- Diagnosed by 13C-UBT within 2 weeks before entry.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- The person in charge of assigning patients to treatment groups does not know which treatments the patients receive, so they do not select patients in order of their own volition. Patients themselves do not know what treatment they are receiving, so they do not change their compliance or reporting of symptoms.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2022
First Posted
August 2, 2022
Study Start
August 1, 2022
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
August 2, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- The data will be available after August 31, 2025, and will be permanently public.
- Access Criteria
- Everyone