Ancillary Microbiome Collection From Mother/Infant Pairs... | NCT03236194

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

NCT03236194

Sponsor

Milton S. Hershey Medical Center

Status

Completed

Last Update Posted

Mar 4, 2019Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Infant Development

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 17, 2017Actual

Primary Completion Date

Dec 15, 2017Actual

Completion Date

Jan 30, 2019Actual

First Submitted Date

Jul 25, 2017

First Submission Date that Met QC Criteria

Jul 27, 2017

First Posted Date

Aug 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2019

Last Update Posted Date

Mar 4, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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 CenterPrincipal Investigator

Lead Sponsor

Milton S. Hershey Medical CenterOTHER

Collaborators

Name	Class
Penn State University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Genetic variation	Associations between genetic variation and microbiome diversity	birth to 1 year
Genetic variation	Genetic variation as it relates to growth outcomes

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Penn State Milton S Hershey Medical Center		Hershey	Pennsylvania	17033	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27628595	Background	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.
25798435	Background	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.