The Efficacy of Treatment for Helicobacter Pylori Infection in Preschooler by Yoghurt With LG21

Study Overview
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Brief Summary
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The goal of this 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 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.

Official Title
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A Randomized, Open-Label Trial of the Efficacy of Treatment for Helicobacter Pylori Infection in Preschooler by Yoghurt With LG21

Conditions
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H. Pylori Infection

Intervention / Treatment
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* Dietary Supplement: Meiji Yogurt Group


Participation Criteria
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Eligibility Criteria
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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 randomization (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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Meiji Yogurt Group<br>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 grigi, Lactobacillus bulgaricus, Streptococcus thermophilus. | Dietary Supplement: Meiji Yogurt Group<br>* Participants in this arm need to eat assigned product for 12 weeks, one bottle each day.<br>|
| No Intervention: Blank Control Group<br>No interventional product for this arm | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori Stool Antigen Test | The stool of the participants will be assessed by Helicobacter pylori Stool Antigen Test (HpSA) on the last day of the study. A negative result indicates that participant is infection-free. | baseline day 0, day 112 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori Stool Antigen Test | The stool of the participants will be assessed by Helicobacter pylori Stool Antigen Test (HpSA) on the day 42 and day 84 from the baseline day. A negative result indicates that participant is infection-free. | day 42, day 84 | 
| Score of Bristol Stool Scale | The stool of the participants will be assessed by Bristol Stool Scale, type 1 to type 7, mapping to a score from 1 to 7. where 1 to 7 means stools are from hardest to loosest. Normal stools are those in the middle of the chart, in the 3 to 4 range. | baseline day 0, day 42, day 84, day 112 | 
| Frequency of Defecation | The frequency of defecation of participants each day during the study | baseline day 0 to day 112 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meiji Yoghurt LG21, Helicobacter pylori stool antigen test, Preschooler