The Efficacy of Treatment for Helicobacter Pylori Infection in Preschooler by Yoghurt With LG21
NCT ID: NCT06045494
Last Updated: 2023-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
140 participants
INTERVENTIONAL
2023-09-26
2024-01-30
Brief Summary
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\- 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Meiji Yogurt Group
Participants in this arm need to eat assigned product for 12 weeks, one bottle each day.
Blank Control Group
No interventional product for this arm
No interventions assigned to this group
Interventions
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Meiji Yogurt Group
Participants in this arm need to eat assigned product for 12 weeks, one bottle each day.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
4 Years
6 Years
ALL
No
Sponsors
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Meiji China Investment Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Wei Zhuang, MD
Role: PRINCIPAL_INVESTIGATOR
Jinhua Wenrong Hospital
Toshihiro Otsu, PhD
Role: PRINCIPAL_INVESTIGATOR
Meiji China Investment Co.,Ltd
Locations
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Kaitai Biotech Lab
Hangzhou, Zhejiang, China
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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23-SM-04-MJ-001
Identifier Type: -
Identifier Source: org_study_id