Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-01-06 @ 10:56 AM
Study NCT ID:
NCT03236194
Status:
COMPLETED
Last Update Posted:
2019-03-04
First Post:
2017-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ancillary Microbiome Collection From Mother/Infant Pairs During First Year of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'microbiome samples from mother and infant'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-28', 'studyFirstSubmitDate': '2017-07-25', 'studyFirstSubmitQcDate': '2017-07-27', 'lastUpdatePostDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbiome outcome', 'timeFrame': 'birth to 1 year', 'description': 'Microbiome diversity within individuals (how gut and oral microbiomes are similar or different) and between individuals'}], 'secondaryOutcomes': [{'measure': 'Genetic variation', 'timeFrame': 'birth to 1 year', 'description': 'Associations between genetic variation and microbiome diversity'}, {'measure': 'Genetic variation', 'timeFrame': 'birth to 1 year', 'description': 'Genetic variation as it relates to growth outcomes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infant Development']}, 'referencesModule': {'references': [{'pmid': '27628595', 'type': 'BACKGROUND', 'citation': 'Gomez A, Nelson KE. The Oral Microbiome of Children: Development, Disease, and Implications Beyond Oral Health. Microb Ecol. 2017 Feb;73(2):492-503. doi: 10.1007/s00248-016-0854-1. Epub 2016 Sep 14.'}, {'pmid': '25798435', 'type': 'BACKGROUND', 'citation': 'Gritz EC, Bhandari V. The human neonatal gut microbiome: a brief review. Front Pediatr. 2015 Mar 5;3:17. doi: 10.3389/fped.2015.00017. eCollection 2015.'}, {'pmid': '28112736', 'type': 'BACKGROUND', 'citation': 'Chu DM, Ma J, Prince AL, Antony KM, Seferovic MD, Aagaard KM. Maturation of the infant microbiome community structure and function across multiple body sites and in relation to mode of delivery. Nat Med. 2017 Mar;23(3):314-326. doi: 10.1038/nm.4272. Epub 2017 Jan 23.'}, {'pmid': '26308884', 'type': 'BACKGROUND', 'citation': 'Backhed F, Roswall J, Peng Y, Feng Q, Jia H, Kovatcheva-Datchary P, Li Y, Xia Y, Xie H, Zhong H, Khan MT, Zhang J, Li J, Xiao L, Al-Aama J, Zhang D, Lee YS, Kotowska D, Colding C, Tremaroli V, Yin Y, Bergman S, Xu X, Madsen L, Kristiansen K, Dahlgren J, Wang J. Dynamics and Stabilization of the Human Gut Microbiome during the First Year of Life. Cell Host Microbe. 2015 Jun 10;17(6):852. doi: 10.1016/j.chom.2015.05.012. Epub 2015 Jun 10. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will be studying the development of the microbiome over the first year after birth in light of various environmental influences - e.g. mode of delivery, diet (and diet changes), antibiotic exposure, GERD medication exposure.', 'detailedDescription': "Microbiome samples will be collected from mother/infant pairs during post-natal hospital stay through the first year of life. Investigators will perform statistical analyses to test the hypotheses (1) that there is an association between the developing oral and gut microbiomes, and (2) that they interact in affecting childhood obesity.\n\nThis study relates to the INSIGHT study (NCT01167270) and its last outcome measure; exploring oral and gut microbiome collected from that study's second born participants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy full-term mothers and infants delivering at the Penn State Milton S Hershey Medical center.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. full-term infant (\\> 36 0/7 weeks gestational age) without significant morbidity\n2. nursery/NICU/maternity stay of 7 days or less\n3. participant children can be (but do not have to be) twins\n4. English speaking mother\n5. care provided at an HMC affiliated clinic\n6. a working telephone number\n\nExclusion Criteria:\n\n1. prenatal ultrasound presence of intrauterine growth retardation (IUGR)\n2. infant birth weight \\<2250 grams\n3. presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease)\n4. any major maternal morbidities and/or pre-existing condition that would affect postpartum care or her ability to care for her newborn such as cancer, multiple sclerosis, lupus, etc.\n5. plan for newborn to be adopted\n6. plan to move from Central Pennsylvania within 1 year\n7. have 2 older siblings in INSIGHT/SIBSIGHT (NIH funded study related to this ancillary study)"}, 'identificationModule': {'nctId': 'NCT03236194', 'briefTitle': 'Ancillary Microbiome Collection From Mother/Infant Pairs During First Year of Life', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Ancillary Microbiome Collection From Mother/Infant Pairs During First Year of Life', 'orgStudyIdInfo': {'id': 'PRAMS034493EP'}}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Milton S Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Penn State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics and Public Health Sciences Chief, Division of Academic General Pediatrics Vice Chair of Clinical Affairs, Department of Pediatrics', 'investigatorFullName': 'Ian M. Paul, MD', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}