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H. Pylori InfectionNCT06045494

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

A study testing Meiji Yogurt Group in people with H. Pylori Infection, run by Meiji China Investment Co.,Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 6 years
Conditions the study is for
H. Pylori Infection
What is being tested?
Meiji Yogurt Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteChina
Study dates
26 Sep 2023to 30 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Kaitai Biotech Lab

    Hangzhou, Zhejiang

Other trials in China

About this study

Official title: A Non-Randomized, Open-Label Trial of 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.

Being tested
Meiji Yogurt Group
Keywords
Meiji Yoghurt LG21, Helicobacter pylori stool antigen test, Preschooler

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meiji Yogurt GroupDietary supplement

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

Study groups in NCT06045494
Study groupRoleWhat they receive
Meiji Yogurt GroupActive comparatorMeiji 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.
Receives: Dietary Supplement: Meiji Yogurt Group
Blank Control GroupNo interventionNo interventional product for this arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline day 0, day 42, day 84, day 112

Secondary outcomes (5)

  1. 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

    Measured: baseline day 0, day 42, day 84, day 112

  2. 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.

    Measured: baseline day 0, day 42, day 84, day 112

  3. 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.

    Measured: baseline day 0, day 42, day 84, day 112

  4. 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.

    Measured: baseline day 0, day 84

  5. Salivary amylase and cortisol levels

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

    Measured: baseline day 0, day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start26 Sep 2023
  3. Primary completion16 Jan 2024
  4. Study completion30 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06045494
Sponsor's protocol ID
23-SM-04-MJ-001
Status last verified
Feb 2026
First submitted
13 Sep 2023
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34836916

  • 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.

    PubMed 29512258

  • 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.

    PubMed 37435093

  • 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.

    PubMed 19702850

Questions about this trial

What is this clinical trial studying?

A study testing Meiji Yogurt Group in people with H. Pylori Infection, run by Meiji China Investment Co.,Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06045494, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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