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

• ClinicalTrials.gov Identifier: NCT06045494
• Recruitment Status: Active, not recruiting
• First Posted: September 21, 2023
• Last Update Posted: November 21, 2023
• Sponsor: Meiji China Investment Co.,Ltd
• Information provided by (Responsible Party): Meiji China Investment Co.,Ltd

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.

Condition or disease	Intervention/treatment	Phase
H. Pylori Infection	Dietary Supplement: Meiji Yogurt Group	Not Applicable

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. Frequency of Defecation [ Time Frame: baseline day 0 to day 112 ]
   The frequency of defecation of participants each day during the study

Eligibility Criteria

• Ages Eligible for Study: 4 Years to 6 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

China, Zhejiang

Kaitai Biotech Lab

Hangzhou, Zhejiang, China

Sponsors and Collaborators

Meiji China Investment Co.,Ltd

Investigators

• Principal Investigator: Wei Zhuang, MD; Jinhua Wenrong Hospital
• Principal Investigator: Toshihiro Otsu, PhD; Meiji China Investment Co.,Ltd

More Information

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.

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.

• 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
• 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

Keywords provided by Meiji China Investment Co.,Ltd:

Meiji Yoghurt LG21; Helicobacter pylori stool antigen test; Preschooler

Additional relevant MeSH terms:

Infections; Communicable Diseases; Disease Attributes; Pathologic Processes