The Efficacy of Treatment for Helicobacter Pylori Infection in Preschooler by Yoghurt With LG21
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ClinicalTrials.gov Identifier: NCT06045494 |
Recruitment Status :
Active, not recruiting
First Posted : September 21, 2023
Last Update Posted : November 21, 2023
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The goal of this 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 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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
H. Pylori Infection | Dietary Supplement: Meiji Yogurt Group | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 140 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | A Randomized, Open-Label Trial of the Efficacy of Treatment for Helicobacter Pylori Infection in Preschooler by Yoghurt With LG21 |
Actual Study Start Date : | September 26, 2023 |
Estimated Primary Completion Date : | January 16, 2024 |
Estimated Study Completion Date : | January 30, 2024 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Meiji Yogurt Group
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 grigi, Lactobacillus bulgaricus, Streptococcus thermophilus. |
Dietary Supplement: Meiji Yogurt Group
Participants in this arm need to eat assigned product for 12 weeks, one bottle each day. |
No Intervention: Blank Control Group
No interventional product for this arm
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- Helicobacter pylori Stool Antigen Test [ Time Frame: baseline day 0, day 112 ]The stool of the participants will be assessed by Helicobacter pylori Stool Antigen Test (HpSA) on the last day of the study. A negative result indicates that participant is infection-free.
- Helicobacter pylori Stool Antigen Test [ Time Frame: day 42, day 84 ]The stool of the participants will be assessed by Helicobacter pylori Stool Antigen Test (HpSA) on the day 42 and day 84 from the baseline day. A negative result indicates that participant is infection-free.
- Score of Bristol Stool Scale [ Time Frame: baseline day 0, day 42, day 84, 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. where 1 to 7 means stools are from hardest to loosest. Normal stools are those in the middle of the chart, in the 3 to 4 range.
- Frequency of Defecation [ Time Frame: baseline day 0 to day 112 ]The frequency of defecation of participants each day during the study
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Ages Eligible for Study: | 4 Years to 6 Years (Child) |
Sexes Eligible for Study: | All |
Accepts 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 randomization (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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045494
China, Zhejiang | |
Kaitai Biotech Lab | |
Hangzhou, Zhejiang, China |
Principal Investigator: | Wei Zhuang, MD | Jinhua Wenrong Hospital | |
Principal Investigator: | Toshihiro Otsu, PhD | Meiji China Investment Co.,Ltd |
Responsible Party: | Meiji China Investment Co.,Ltd |
ClinicalTrials.gov Identifier: | NCT06045494 |
Other Study ID Numbers: |
23-SM-04-MJ-001 |
First Posted: | September 21, 2023 Key Record Dates |
Last Update Posted: | November 21, 2023 |
Last Verified: | November 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Meiji Yoghurt LG21 Helicobacter pylori stool antigen test Preschooler |
Infections Communicable Diseases Disease Attributes Pathologic Processes |