Ancillary Microbiome Collection From Mother/Infant Pairs During First Year of Life
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infant Development
- Sponsor
- Milton S. Hershey Medical Center
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Microbiome outcome
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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. This 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.
Investigators
Ian M. Paul, MD
Professor of Pediatrics and Public Health Sciences Chief, Division of Academic General Pediatrics Vice Chair of Clinical Affairs, Department of Pediatrics
Milton S. Hershey Medical Center
Eligibility Criteria
Inclusion Criteria
- •full-term infant (\> 36 0/7 weeks gestational age) without significant morbidity
- •nursery/NICU/maternity stay of 7 days or less
- •participant children can be (but do not have to be) twins
- •English speaking mother
- •care provided at an HMC affiliated clinic
- •a working telephone number
Exclusion Criteria
- •prenatal ultrasound presence of intrauterine growth retardation (IUGR)
- •infant birth weight \<2250 grams
- •presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease)
- •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.
- •plan for newborn to be adopted
- •plan to move from Central Pennsylvania within 1 year
- •have 2 older siblings in INSIGHT/SIBSIGHT (NIH funded study related to this ancillary study)
Outcomes
Primary Outcomes
Microbiome outcome
Time Frame: birth to 1 year
Microbiome diversity within individuals (how gut and oral microbiomes are similar or different) and between individuals
Secondary Outcomes
- Genetic variation(birth to 1 year)