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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
140
Participants in this arm need to eat assigned product for 12 weeks, one bottle each day.
Kaitai Biotech Lab
Hangzhou, Zhejiang, China
H. pylori-negative conversion rate and the levels of H. pylori antigen measured and confirmed through fecal H. pylori antigen tests at each visit.
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.
Time frame: baseline day 0, day 42, day 84, day 112
Gastrointestinal symptom scores
A questionnaire will be administered in which parents will report on 12 gastrointestinal symptoms related to their child's esophagus, stomach, and lower abdomen over the past week on baseline day 0, day 42, day 84, and day 112. The following symptoms will be evaluated using a 7-point Likert scale
Time frame: baseline day 0, day 42, day 84, day 112
Stool frequency score (using the Bristol stool scale)
A questionnaire will be administered in which parents will report their child's stool frequency over the past week on baseline day 0, day 42, day 84, and day 112. Stool frequency will be assessed using a 5-point Likert scale.
Time frame: baseline day 0, day 42, day 84, day 112
Stool consistency (using the Bristol stool scale)
A questionnaire will be administered in which parents will report their child's stool consistency over the past week on baseline day 0, day 42, day 84, and 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.
Time frame: baseline day 0, day 42, day 84, day 112
The problem behavior scores (using the Child Behavior Checklist, CBCL)
The Chinese version of the Preschool Child Behavior Checklist (CBCL) (1.5-5) will be used on baseline day 0 and day 84. The parents will be asked to describe their child's behavior now or within the past 2 months on a Likert scale.
Time frame: baseline day 0, day 84
Salivary amylase and cortisol levels
The concentrations of salivary cortisol (µg/L) and salivary amylase (µM/L)
Time frame: baseline day 0, day 84
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