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NCT Number: NCT06045494

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

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.

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Key information

Conditions

H. Pylori Infection

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaitai Biotech Lab

Hangzhou, Zhejiang, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meiji Yogurt Group

Dietary Supplement

Participants in this arm need to eat assigned product for 12 weeks, one bottle each day.

Primary outcomes

  1. 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

  1. Gastrointestinal symptom scores

    Time frame: 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

  2. Stool frequency score (using the Bristol stool scale)

    Time frame: 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.

  3. Stool consistency (using the Bristol stool scale)

    Time frame: 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.

  4. The problem behavior scores (using the Child Behavior Checklist, CBCL)

    Time frame: 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.

  5. Salivary amylase and cortisol levels

    Time frame: baseline day 0, day 84

    The concentrations of salivary cortisol (µg/L) and salivary amylase (µM/L)

Sponsors and collaborators

Lead sponsor

Meiji China Investment Co.,Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2023
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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