NCT03236194

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

March 4, 2019

Status Verified

February 1, 2019

Enrollment Period

5 months

First QC Date

July 25, 2017

Last Update Submit

February 28, 2019

Conditions

Infant Development

Outcome Measures

Primary Outcomes (1)

  • Microbiome outcome

    Microbiome diversity within individuals (how gut and oral microbiomes are similar or different) and between individuals

    birth to 1 year

Secondary Outcomes (2)

  • Genetic variation

    birth to 1 year

  • Genetic variation

    birth to 1 year

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy full-term mothers and infants delivering at the Penn State Milton S Hershey Medical center.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (4)

  • 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: 27628595BACKGROUND

  • 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: 25798435BACKGROUND

  • 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: 28112736BACKGROUND

  • 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.

    PMID: 26308884BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

microbiome samples from mother and infant

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics and Public Health Sciences Chief, Division of Academic General Pediatrics Vice Chair of Clinical Affairs, Department of Pediatrics

Study Record Dates

First Submitted

July 25, 2017

First Posted

August 1, 2017

Study Start

July 17, 2017

Primary Completion

December 15, 2017

Study Completion

January 30, 2019

Last Updated

March 4, 2019

Record last verified: 2019-02

Locations

US(1)