The Efficacy of Treatment for Helicobacter Pylori Infection in Preschooler by Yoghurt With LG21
- Conditions
- H. Pylori Infection
- Interventions
- Dietary Supplement: Meiji Yogurt Group
- Registration Number
- NCT06045494
- Lead Sponsor
- Meiji China Investment Co.,Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 140
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Meiji Yogurt Group 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 grigi, Lactobacillus bulgaricus, Streptococcus thermophilus.
- Primary Outcome Measures
Name Time Method Helicobacter pylori Stool Antigen Test baseline day 0, day 112 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.
- Secondary Outcome Measures
Name Time Method Frequency of Defecation baseline day 0 to day 112 The frequency of defecation of participants each day during the study
Score of Bristol Stool Scale baseline day 0, day 42, day 84, day 112 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.
Helicobacter pylori Stool Antigen Test day 42, day 84 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.
Trial Locations
- Locations (1)
Kaitai Biotech Lab
🇨🇳Hangzhou, Zhejiang, China