A Non-Randomized, Open-Label Trial of the Efficacy of Treatment for Helicobacter Pylori Infection in Preschooler by Yoghurt With LG21
Overview
- Phase
- N/A
- Intervention
- Meiji Yogurt Group
- Conditions
- H. Pylori Infection
- Sponsor
- Meiji China Investment Co.,Ltd
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- H. pylori-negative conversion rate and the levels of H. pylori antigen measured and confirmed through fecal H. pylori antigen tests at each visit.
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
The goal of this non-randomized, open-label, interventional trial is to study the efficacy of treatment for Helicobacter Pylori Infection in Preschooler aged 4-6 by Meiji Yoghurt with LG21. The main question it aims to answer is:
- whether the treatment by Meiji Yoghurt LG21 is effective by stool antigen (HpSA) test
140 qualified participants will be enrolled and non-randomized into 2 groups of the same size (product study group and blank control group). Participants of the product study group will need to eat assigned Meiji Yoghurt for 12 weeks, one bottle each day, while participants of the blank control group won't receive any intervention during the study. Four visits will be made for all participants, and relevant clinical data will be captured and recorded into CTMS (Clinical Trial Management System) for statistical analysis and reporting.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Preschooler aged 4-6 years
- •H. pylori positive
- •Drink milk or milk beverages regularly (more than three times a week) before joining the study
- •ICF signed
- •Parents or guardians agree not to participate in other interventional clinical studies during this study
Exclusion Criteria
- •Has potential metabolic class or chronic disease
- •Use of antibiotics within 7 days before allocation (as judged by the trial responsible physician)
- •People who have been treated for eradication of Helicobacter pylori
- •Pharmaceuticals, medicinal skin care products (medical external products) and health foods that may affect gastric symptoms have been commonly used since more than one month ago
- •Already under digestive system treatment
- •Has lactose intolerance or protein allergy
- •Those whose families had plans to leave Jinhua City during the study period
- •Fails to comply with the provisions of the protocol
- •Those who are deemed unsuitable as subjects by the physician
Arms & Interventions
Meiji Yogurt Group
Meiji LG21 yogurt: 180 g/bottle, main ingredients: Raw milk, water, sugar, skim milk powder, food additives (hydroxypropyl distarch phosphate, pectin), cream, whey protein powder, food flavor, Lactobacillus paragasseri, Lactobacillus bulgaricus, Streptococcus thermophilus.
Intervention: Meiji Yogurt Group
Blank Control Group
No interventional product for this arm
Outcomes
Primary Outcomes
H. pylori-negative conversion rate and the levels of H. pylori antigen measured and confirmed through fecal H. pylori antigen tests at each visit.
Time Frame: baseline day 0, day 42, day 84, day 112
The stool of the participants will be assessed by Helicobacter pylori Stool Antigen Test (HpSA) on baseline day 0, day 42, day 84, and day 112. A negative result indicates that participant is infection-free.
Secondary Outcomes
- Gastrointestinal symptom scores(baseline day 0, day 42, day 84, day 112)
- Stool frequency score (using the Bristol stool scale)(baseline day 0, day 42, day 84, day 112)
- Stool consistency (using the Bristol stool scale)(baseline day 0, day 42, day 84, day 112)
- The problem behavior scores (using the Child Behavior Checklist, CBCL)(baseline day 0, day 84)
- Salivary amylase and cortisol levels(baseline day 0, day 84)