Back to resultsThe Efficacy of Treatment for Helicobacter Pylori Infection in Preschooler by Yoghurt With LG21
Primary Purpose
H. Pylori Infection
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Meiji Yogurt Group
Sponsored by
About this trial
This is an interventional supportive care trial for H. Pylori Infection focused on measuring Meiji Yoghurt LG21, Helicobacter pylori stool antigen test, Preschooler
Eligibility Criteria
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
Sites / Locations
- Jinhua Wenrong HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Meiji Yogurt Group
Blank Control Group
Arm Description
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.
No interventional product for this arm
Outcomes
Primary Outcome Measures
Helicobacter pylori Stool Antigen Test
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.
Secondary Outcome Measures
Helicobacter pylori Stool Antigen Test
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
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.
Frequency of Defecation
The frequency of defecation of participants each day during the study
Full Information
NCT ID
NCT06045494
First Posted
September 13, 2023
Last Updated
September 13, 2023
Sponsor
Meiji China Investment Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT06045494
Brief Title
The Efficacy of Treatment for Helicobacter Pylori Infection in Preschooler by Yoghurt With LG21
Official Title
A Randomized, Open-Label Trial of the Efficacy of Treatment for Helicobacter Pylori Infection in Preschooler by Yoghurt With LG21
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2023 (Anticipated)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meiji China Investment Co.,Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
H. Pylori Infection
Keywords
Meiji Yoghurt LG21, Helicobacter pylori stool antigen test, Preschooler
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Meiji Yogurt Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Blank Control Group
Arm Type
No Intervention
Arm Description
No interventional product for this arm
Intervention Type
Dietary Supplement
Intervention Name(s)
Meiji Yogurt Group
Intervention Description
Participants in this arm need to eat assigned product for 12 weeks, one bottle each day.
Primary Outcome Measure Information:
Title
Helicobacter pylori Stool Antigen Test
Description
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.
Time Frame
baseline day 0, day 112
Secondary Outcome Measure Information:
Title
Helicobacter pylori Stool Antigen Test
Description
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.
Time Frame
day 42, day 84
Title
Score of Bristol Stool Scale
Description
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.
Time Frame
baseline day 0, day 42, day 84, day 112
Title
Frequency of Defecation
Description
The frequency of defecation of participants each day during the study
Time Frame
baseline day 0 to day 112
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlie Zhang, MD
Phone
+8613901981272
Email
charlie.zhang@sprimmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Zhuang, MD
Organizational Affiliation
Jinhua Wenrong Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Toshihiro Otsu, PhD
Organizational Affiliation
Meiji China Investment Co.,Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinhua Wenrong Hospital
City
Jinhua
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlie BC Zhang, MD
Phone
+8613901981272
Email
charlie.zhang@sprimmedical.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34836916
Citation
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.
Results Reference
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PubMed Identifier
29512258
Citation
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.
Results Reference
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PubMed Identifier
37435093
Citation
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.
Results Reference
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PubMed Identifier
19702850
Citation
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.
Results Reference
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The Efficacy of Treatment for Helicobacter Pylori Infection in Preschooler by Yoghurt With LG21
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