Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-01-05 @ 8:34 PM
Study NCT ID:
NCT06045494
Status:
UNKNOWN
Last Update Posted:
2023-11-21
First Post:
2023-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Treatment for Helicobacter Pylori Infection in Preschooler by Yoghurt With LG21
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2023-09-13', 'studyFirstSubmitQcDate': '2023-09-13', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Helicobacter pylori Stool Antigen Test', 'timeFrame': 'baseline day 0, day 112', '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.'}], 'secondaryOutcomes': [{'measure': 'Helicobacter pylori Stool Antigen Test', 'timeFrame': 'day 42, day 84', '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.'}, {'measure': 'Score of Bristol Stool Scale', 'timeFrame': 'baseline day 0, day 42, day 84, day 112', '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. 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.'}, {'measure': 'Frequency of Defecation', 'timeFrame': 'baseline day 0 to day 112', 'description': 'The frequency of defecation of participants each day during the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Meiji Yoghurt LG21', 'Helicobacter pylori stool antigen test', 'Preschooler'], 'conditions': ['H. Pylori Infection']}, 'referencesModule': {'references': [{'pmid': '34836916', 'type': 'BACKGROUND', '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.'}, {'pmid': '29512258', 'type': 'BACKGROUND', '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.'}, {'pmid': '37435093', 'type': 'BACKGROUND', '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.'}, {'pmid': '19702850', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': "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:\n\n\\- whether the treatment by Meiji Yoghurt LG21 is effective by stool antigen (HpSA) test\n\n140 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preschooler aged 4-6 years\n* H. pylori positive\n* Drink milk or milk beverages regularly (more than three times a week) before joining the study\n* ICF signed\n* Parents or guardians agree not to participate in other interventional clinical studies during this study\n\nExclusion Criteria:\n\n* Has potential metabolic class or chronic disease\n* Use of antibiotics within 7 days before randomization (as judged by the trial responsible physician)\n* People who have been treated for eradication of Helicobacter pylori\n* 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\n* Already under digestive system treatment\n* Has lactose intolerance or protein allergy\n* Those whose families had plans to leave Jinhua City during the study period\n* Fails to comply with the provisions of the protocol\n* Those who are deemed unsuitable as subjects by the physician'}, 'identificationModule': {'nctId': 'NCT06045494', 'briefTitle': 'The Efficacy of Treatment for Helicobacter Pylori Infection in Preschooler by Yoghurt With LG21', 'organization': {'class': 'INDUSTRY', 'fullName': 'Meiji China Investment Co.,Ltd'}, 'officialTitle': 'A Randomized, Open-Label Trial of the Efficacy of Treatment for Helicobacter Pylori Infection in Preschooler by Yoghurt With LG21', 'orgStudyIdInfo': {'id': '23-SM-04-MJ-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Meiji Yogurt Group', 'description': 'Meiji LG21 yogurt: 180 g/bottle, main ingredients:\n\nRaw milk, water, sugar, skim milk powder, food additives (hydroxypropyl distarch phosphate, pectin), cream, whey protein powder, food flavor, Lactobacillus grigi, Lactobacillus bulgaricus, Streptococcus thermophilus.', 'interventionNames': ['Dietary Supplement: Meiji Yogurt Group']}, {'type': 'NO_INTERVENTION', 'label': 'Blank Control Group', 'description': 'No interventional product for this arm'}], 'interventions': [{'name': 'Meiji Yogurt Group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants in this arm need to eat assigned product for 12 weeks, one bottle each day.', 'armGroupLabels': ['Meiji Yogurt Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Kaitai Biotech Lab', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Wei Zhuang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jinhua Wenrong Hospital'}, {'name': 'Toshihiro Otsu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meiji China Investment Co.,Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meiji China Investment Co.,Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}