H. Pylori Infection
Conditions
Keywords
Meiji Yoghurt LG21, Helicobacter pylori stool antigen test, Preschooler
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.
Interventions
DIETARY_SUPPLEMENTMeiji Yogurt Group
Participants in this arm need to eat assigned product for 12 weeks, one bottle each day.
Sponsors
Meiji China Investment Co.,Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| H. pylori-negative conversion rate and the levels of H. pylori antigen measured and confirmed through fecal H. pylori antigen tests at each visit. | 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
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal symptom scores | baseline day 0, day 42, day 84, day 112 | 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 |
| Stool frequency score (using the Bristol stool scale) | baseline day 0, day 42, day 84, day 112 | 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. |
| Stool consistency (using the Bristol stool scale) | baseline day 0, day 42, day 84, day 112 | 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. |
| The problem behavior scores (using the Child Behavior Checklist, CBCL) | baseline day 0, day 84 | 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. |
| Salivary amylase and cortisol levels | baseline day 0, day 84 | The concentrations of salivary cortisol (µg/L) and salivary amylase (µM/L) |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORWei Zhuang, MD
Jinhua Wenrong Hospital
PRINCIPAL_INVESTIGATORToshihiro Otsu, PhD
Meiji China Investment Co.,Ltd
Outcome results
None listed