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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-17

Study Completion Date

2019-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Microbiome, Antibiotics, and Growth Infant Cohort

NCT03001167

Obesity, Childhood Antibiotic Side Effect

COMPLETED

Dynamics of the Microbiome in the Premature Infant

NCT02121938

Infection

COMPLETED

Prenatal Antibiotics and Breast Milk / Neonatal IgA

NCT05813184

Dysbiosis Neonatal Infection Prenatal Exposure Delayed Effects +2 more

RECRUITING

Antibiotic Exposure During Pregnancy Affects Infant Gut Microbiota

NCT06479941

Antibiotics Affecting Newborn Gut Microbiota

RECRUITING

Potential Restoration of the Infant Microbiome

NCT02407184

Human Microbiome

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infant Development

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

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

Responsibility Role PRINCIPAL_INVESTIGATOR