Ancillary Microbiome Collection From Mother/Infant Pairs During First Year of Life

Completed

• Conditions: Infant Development

• Registration Number: NCT03236194
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Study Timeline

• Study Start: 2017-07-17
• Study First Submitted: 2017-07-25
• Study First Submitted QC: 2017-07-27
• Study First Posted: 2017-08-01
• Primary Completion: 2017-12-15
• Study Completion: 2019-01-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-28
• Last Update Posted: 2019-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. full-term infant (> 36 0/7 weeks gestational age) without significant morbidity
2. nursery/NICU/maternity stay of 7 days or less
3. participant children can be (but do not have to be) twins
4. English speaking mother
5. care provided at an HMC affiliated clinic
6. a working telephone number

Exclusion Criteria

1. prenatal ultrasound presence of intrauterine growth retardation (IUGR)
2. infant birth weight <2250 grams
3. presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease)
4. 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.
5. plan for newborn to be adopted
6. plan to move from Central Pennsylvania within 1 year
7. have 2 older siblings in INSIGHT/SIBSIGHT (NIH funded study related to this ancillary study)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Microbiome outcome	birth to 1 year	Microbiome diversity within individuals (how gut and oral microbiomes are similar or different) and between individuals

Secondary Outcome Measures

Name	Time	Method
Genetic variation	birth to 1 year	Genetic variation as it relates to growth outcomes

Trial Locations

Locations (1)

Penn State Milton S Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States