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

H. Pylori Infection Clinical Trial

Official title:

A Randomized, Open-Label Trial of the Efficacy of Treatment for Helicobacter Pylori Infection in Preschooler by Yoghurt With LG21

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06045494
• Other study ID #: 23-SM-04-MJ-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 26, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: November 2023
• Source: Meiji China Investment Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: January 30, 2024
• Est. primary completion date: January 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• H. Pylori Infection
• Infections

Intervention

Dietary Supplement:
• Meiji Yogurt Group
Participants in this arm need to eat assigned product for 12 weeks, one bottle each day.

Locations

Country	Name	City	State
China	Kaitai Biotech Lab	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Meiji China Investment Co.,Ltd

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline day 0, day 112
Secondary	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.	day 42, day 84
Secondary	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. 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.	baseline day 0, day 42, day 84, day 112
Secondary	Frequency of Defecation	The frequency of defecation of participants each day during the study	baseline day 0 to day 112