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

NCT06045494 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-02-13

No results posted yet for this study

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.

Conditions

  • H. Pylori Infection

Interventions

DIETARY_SUPPLEMENT

Meiji Yogurt Group

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

Sponsors & Collaborators

  • Meiji China Investment Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Wei Zhuang, MD · Jinhua Wenrong Hospital

  • Toshihiro Otsu, PhD · Meiji China Investment Co.,Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-26
Primary Completion
2024-01-16
Completion
2024-01-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06045494 on ClinicalTrials.gov