NCT06045494

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

September 26, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

September 13, 2023

Last Update Submit

February 11, 2026

Conditions

H. Pylori Infection

Keywords

Meiji Yoghurt LG21Helicobacter pylori stool antigen testPreschooler

Outcome Measures

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.

    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.

    baseline day 0, day 42, day 84, day 112

Secondary Outcomes (5)

  • Gastrointestinal symptom scores

    baseline day 0, day 42, day 84, day 112

  • Stool frequency score (using the Bristol stool scale)

    baseline day 0, day 42, day 84, day 112

  • Stool consistency (using the Bristol stool scale)

    baseline day 0, day 42, day 84, day 112

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

    baseline day 0, day 84

  • Salivary amylase and cortisol levels

    baseline day 0, day 84

Study Arms (2)

Meiji Yogurt Group

ACTIVE COMPARATOR

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 paragasseri, Lactobacillus bulgaricus, Streptococcus thermophilus.

Dietary Supplement: Meiji Yogurt Group

Blank Control Group

NO INTERVENTION

No interventional product for this arm

Interventions

Meiji Yogurt GroupDIETARY_SUPPLEMENT

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

Meiji Yogurt Group

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaitai Biotech Lab

Hangzhou, Zhejiang, China

Location

Related Publications (4)

  • Ding SZ, Du YQ, Lu H, Wang WH, Cheng H, Chen SY, Chen MH, Chen WC, Chen Y, Fang JY, Gao HJ, Guo MZ, Han Y, Hou XH, Hu FL, Jiang B, Jiang HX, Lan CH, Li JN, Li Y, Li YQ, Liu J, Li YM, Lyu B, Lu YY, Miao YL, Nie YZ, Qian JM, Sheng JQ, Tang CW, Wang F, Wang HH, Wang JB, Wang JT, Wang JP, Wang XH, Wu KC, Xia XZ, Xie WF, Xie Y, Xu JM, Yang CQ, Yang GB, Yuan Y, Zeng ZR, Zhang BY, Zhang GY, Zhang GX, Zhang JZ, Zhang ZY, Zheng PY, Zhu Y, Zuo XL, Zhou LY, Lyu NH, Yang YS, Li ZS; National Clinical Research Center for Digestive Diseases (Shanghai), Gastrointestinal Early Cancer Prevention & Treatment Alliance of China (GECA), Helicobacter pylori Study Group of Chinese Society of Gastroenterology, and Chinese Alliance for Helicobacter pylori Study. Chinese Consensus Report on Family-Based Helicobacter pylori Infection Control and Management (2021 Edition). Gut. 2022 Feb;71(2):238-253. doi: 10.1136/gutjnl-2021-325630. Epub 2021 Nov 26.

    PMID: 34836916BACKGROUND

  • Liu WZ, Xie Y, Lu H, Cheng H, Zeng ZR, Zhou LY, Chen Y, Wang JB, Du YQ, Lu NH; Chinese Society of Gastroenterology, Chinese Study Group on Helicobacter pylori and Peptic Ulcer. Fifth Chinese National Consensus Report on the management of Helicobacter pylori infection. Helicobacter. 2018 Apr;23(2):e12475. doi: 10.1111/hel.12475. Epub 2018 Mar 7.

    PMID: 29512258BACKGROUND

  • Cheng ZY, Gao Y, Mao F, Lin H, Jiang YY, Xu TL, Sun C, Xin L, Li ZS, Wan R, Zhou MG, Wang LW; China Gastrointestinal Health Expert Group (CGHEG). Construction and results of a comprehensive index for gastrointestinal health monitoring in China: a nationwide study. Lancet Reg Health West Pac. 2023 Jun 29;38:100810. doi: 10.1016/j.lanwpc.2023.100810. eCollection 2023 Sep.

    PMID: 37435093BACKGROUND

  • Boonyaritichaikij S, Kuwabara K, Nagano J, Kobayashi K, Koga Y. Long-term administration of probiotics to asymptomatic pre-school children for either the eradication or the prevention of Helicobacter pylori infection. Helicobacter. 2009 Jun;14(3):202-7. doi: 10.1111/j.1523-5378.2009.00675.x.

    PMID: 19702850BACKGROUND

Study Officials

  • Wei Zhuang, MD

    Jinhua Wenrong Hospital

    PRINCIPAL INVESTIGATOR

  • Toshihiro Otsu, PhD

    Meiji China Investment Co.,Ltd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

September 26, 2023

Primary Completion

January 16, 2024

Study Completion

January 30, 2024

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)