Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT03996304
Status:
UNKNOWN
Last Update Posted:
2019-06-24
First Post:
2019-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Health and Early Life Microbiota
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D000073296', 'term': 'Noncommunicable Diseases'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* Faecal samples from study infants\n* Faecal samples from parents\n* Buccal swap DNA sample from study infants\n* Breast milk'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1055}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-21', 'studyFirstSubmitDate': '2019-03-26', 'studyFirstSubmitQcDate': '2019-06-21', 'lastUpdatePostDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Longitudinal change of intestinal microbiota in early life', 'timeFrame': 'From 3 weeks to 2 years after birth', 'description': 'Developmental trajectory of the intestinal microbiota, assessed with 16S rRNA gene amplicon and shotgun sequencing of fecal DNA to determine the changes in the intestinal microbiota composition, diversity and functionality from week 3 to weeks 6,9,12 and months 6,9,12,18 and 24 after birth.'}], 'secondaryOutcomes': [{'measure': 'Number of children with asthma', 'timeFrame': 'At 2 years', 'description': 'Specialist/Physician-diagnosed asthma.'}, {'measure': 'Number of children with allergic disease', 'timeFrame': 'At 2 years', 'description': 'Specialist/Physician-diagnosed wheeze, eczema/atopic dermatitis, allergic rhinitis, food allergy or atopy.'}, {'measure': 'Number of respiratory tract infection episodes', 'timeFrame': 'From birth to 2 years of age', 'description': 'Number of physician-diagnosed respiratory track infections.'}, {'measure': 'Weight', 'timeFrame': 'At 6,12,18 and 24 months after birth', 'description': 'Weight in kilograms.'}, {'measure': 'Growth', 'timeFrame': 'At 6,12,18 and 24 months after birth', 'description': 'Height in centimeters.'}, {'measure': 'Child development', 'timeFrame': 'At 18 and 24 months after birth', 'description': 'By means of questionnaires and, on a randomly selected group of study subjects, developmental testing to assess cognitive, motor, socio-emotional and verbal development.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Birth cohort', 'Intestinal microbiota', 'Child health'], 'conditions': ['Child Development', 'Growth', 'Allergy', 'Overweight', 'Infectious Disease', 'Noncommunicable Diseases']}, 'referencesModule': {'references': [{'pmid': '34857814', 'type': 'DERIVED', 'citation': 'Korpela K, Kallio S, Salonen A, Hero M, Kukkonen AK, Miettinen PJ, Savilahti E, Kohva E, Kariola L, Suutela M, Tarkkanen A, de Vos WM, Raivio T, Kuitunen M. Gut microbiota develop towards an adult profile in a sex-specific manner during puberty. Sci Rep. 2021 Dec 2;11(1):23297. doi: 10.1038/s41598-021-02375-z.'}, {'pmid': '31253623', 'type': 'DERIVED', 'citation': 'Korpela K, Dikareva E, Hanski E, Kolho KL, de Vos WM, Salonen A. Cohort profile: Finnish Health and Early Life Microbiota (HELMi) longitudinal birth cohort. BMJ Open. 2019 Jun 27;9(6):e028500. doi: 10.1136/bmjopen-2018-028500.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this cohort is to identify environmental, lifestyle and genetic factors that modify the human intestinal microbiota development during the first years of life, and to identify early microbiota features that associate to child health and well-being with focus on the development of allergic diseases and overweight.', 'detailedDescription': '1055 healthy term infants born in 2016-2018 mainly at the capital region of Finland, and their parents. Fecal samples collected from infants and their parents. Electronic questionnaires on a weekly basis during the first 4 months of life, thereafter less frequently. Focus on diet, well-being and health and social manners. At one-year and at two-years comprehensive questionnaires including development and cognition. Parental stress evaluation included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The cohort consists of 1055 healthy term infants born in 2016-2018 mainly at the capital region of Finland, and their parents.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* General population, singleton pregnancy, at least one parent Finnish speaking\n* Willingness and ability of parents to consent for 2 year follow-up involving frequent electronic questionnaires and freezing of faecal samples at home\n* Infant born on gestational weeks 37-42 without known congenital defects\n\nExclusion Criteria\n\n* Preterm birth\n* Severe birth defect\n* Parents fail to activate the online questionnaires'}, 'identificationModule': {'nctId': 'NCT03996304', 'acronym': 'HELMi', 'briefTitle': 'Health and Early Life Microbiota', 'organization': {'class': 'OTHER', 'fullName': 'University of Helsinki'}, 'officialTitle': 'Finnish Health and Early Life Microbiota (HELMi) Longitudinal Birth Cohort', 'orgStudyIdInfo': {'id': '263/13/03/03/2015'}}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'country': 'Finland', 'facility': 'Human Microbiome Research Program, Faculty of Medicine, University of Helsinki', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Willem M de Vos, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Helsinki'}, {'name': 'Anne Salonen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Helsinki'}, {'name': 'Kaija-Leena Kolho, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Helsinki'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Helsinki', 'class': 'OTHER'}, 'collaborators': [{'name': 'Business Finland', 'class': 'OTHER'}, {'name': 'Valio Ltd', 'class': 'INDUSTRY'}, {'name': 'Finnish Red Cross Blood Service', 'class': 'OTHER'}, {'name': 'DuPont Nutrition and Health', 'class': 'INDUSTRY'}, {'name': 'Oriola Corporation', 'class': 'UNKNOWN'}, {'name': 'Pikkujätti Medical Centre for Children and Youth', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anne Salonen', 'investigatorAffiliation': 'University of Helsinki'}}}}