Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-01 @ 9:13 PM
Study NCT ID:
NCT06578351
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-04
First Post:
2024-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TRacking Atopic Dermatitis Infants and Their Microbiome (TRAM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Stool sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-03', 'studyFirstSubmitDate': '2024-08-05', 'studyFirstSubmitQcDate': '2024-08-27', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Association between microbiome composition, eczema conditions and known factors that influence the microbiome in early life', 'timeFrame': 'Up to age 18 months', 'description': 'To investigate association between microbiome composition, eczema conditions and known factors that influence the microbiome in early life including mode of delivery, antibiotic prophylaxis, infant feeding patterns and diet.'}, {'measure': 'Association between microbiome composition, dietary/eating patterns, and gut health parameters', 'timeFrame': 'Up to age 18 months', 'description': 'To determine any association between microbiome composition, dietary/eating patterns, and gut health parameters (stool consistency, frequency, colour, constipation, gastrointestinal infection, antibiotic intake) including stool images.'}], 'primaryOutcomes': [{'measure': "user experience using a survey form to evaluate user's understanding of OneBiome report", 'timeFrame': 'Up to age 18 months', 'description': 'user experience of reading and understanding the microbiome and eating pattern analysis reports.'}, {'measure': "user experience using a survey form to evaluate user's perspective on using OneBiome report to monitor microbiome and eating pattern", 'timeFrame': 'Up to age 18 months', 'description': 'User experience of using and understanding the microbiome and nutrition platforms that allow parents to monitor microbiome and eating patterns of their child overtime.'}], 'secondaryOutcomes': [{'measure': 'HCP reported applicability of OneBiome concept by parents via a survey form', 'timeFrame': 'Up to age 18 months', 'description': "HCP reported applicability of microbiome/eating pattern profiles of their patients for their general practice, and to assess parents' overall feedback on OneBiome concept."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microbiome', 'atopic dermatitis', 'pediatric'], 'conditions': ['Atopic Dermatitis', 'Pediatric ALL']}, 'descriptionModule': {'briefSummary': 'TRacking Atopic dermatitis Infants and their Microbiome: A study to primarily assess the user experience of parents of infants with early onset eczema and parents of healthy infants on OneBiome real-world evidence research platform.', 'detailedDescription': 'Parents of healthy infants as well as parents of infants with early onset eczema:\n\n* user experience of reading and understanding the microbiome and eating pattern analysis reports\n* user experience of using and understanding the microbiome and nutrition platforms that allow parents to monitor microbiome and eating patterns of their child overtime'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '0 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infants with early onset eczema (n=30, \\<12 months of age) and healthy infants (n=30, \\<6 months of age).', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Infants diagnosed with early onset eczema (\\<12 months of age) and healthy infants (\\<6 months of age, before weaning).\n2. Parents of children should have access to the internet and a smartphone or tablet to access the OneBiome mobile friendly website.\n3. Parents of children should be able to comprehend the content in the OneBiome mobile friendly website and complete the questionnaires in English.\n4. Parents of children should stay in Singapore and remain contactable.\n\nExclusion Criteria:\n\n1. Children born prematurely.\n2. Children with a chronic illness.\n3. Children with congenital malformations, surgeries in the neonatal period or genetic syndromes.\n4. Incapability of the parents of children to access OneBiome mobile friendly website and complete the questionnaires in English.\n5. Any other family member is enrolled in the study.\n6. Incapability of the parents of children to comply with study protocol or investigator's uncertainty about the willingness or ability of the parents of children to comply with the protocol requirements."}, 'identificationModule': {'nctId': 'NCT06578351', 'acronym': 'TRAM', 'briefTitle': 'TRacking Atopic Dermatitis Infants and Their Microbiome (TRAM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Danone Asia Pacific Holdings Pte, Ltd.'}, 'officialTitle': 'TRacking Atopic Dermatitis Infants and Their Microbiome (TRAM)', 'orgStudyIdInfo': {'id': 'SBB20R&33310_A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Infants', 'description': 'Healthy. no atopic dermatitis'}, {'label': 'Infants with early onset of eczema', 'description': 'diagnosed with early onset eczema'}]}, 'contactsLocationsModule': {'locations': [{'zip': '228510', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Mount Elizabeth Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Bee Wah Lee, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Child and Allergy Clinic - Mount Elizabeth Hospital'}, {'name': 'Wen Chin Chiang, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Chiang's Children Allergy and Asthma Clinic - Mount Elizabeth Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danone Asia Pacific Holdings Pte, Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}