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Completed

NCT Number: NCT03236194

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

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.

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Key information

Conditions

Infant Development

Sex eligibility

All sexes

Study type

Observational

Primary location

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

  1. Genetic variation

    Time frame: birth to 1 year

    Associations between genetic variation and microbiome diversity

  2. Genetic variation

    Time frame: birth to 1 year

    Genetic variation as it relates to growth outcomes

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • Penn State University

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2019
First posted
Aug 1, 2017
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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