Microbiome, Antibiotics, and Growth Infant Cohort

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

509 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-09

Study Completion Date

2023-06-09

Brief Summary

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

This cross-disciplinary study will assemble and longitudinally follow a large, diverse birth cohort to determine the relationships between early life antibiotic exposure, microbiome development, growth, antibodies, and immunostimulation.

Related Clinical Trials

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

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

NCT03236194

Infant Development

COMPLETED

Antibiotic Exposure During Pregnancy Affects Infant Gut Microbiota

NCT06479941

Antibiotics Affecting Newborn Gut Microbiota

RECRUITING

The Effects of Antibiotic Exposure in Early Infancy on Vaccine Responses

NCT06079606

Immune Responses Antibiotic Treatment

ACTIVE_NOT_RECRUITING

Prenatal Antibiotics and Breast Milk / Neonatal IgA

NCT05813184

Dysbiosis Neonatal Infection Prenatal Exposure Delayed Effects +2 more

RECRUITING

Effects of IAP-EOGBSD on Offspring's Gut Microbiome and Immunity.

NCT05738460

Healthy Metabolism Microbiome

UNKNOWN

Detailed Description

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

Perinatal and infant antibiotic exposures are common and have been linked to changes in the gut microbiome, which plays a central role in health and disease. Childhood obesity is an epidemic and animal models have linked antibiotic induced changes in the microbiome with increased adiposity. Infants become colonized with trillions of bacteria in the first few hours of life. During this time period, their nascent immune system develops tolerance to commensal microbes

The primary objectives are to measure the impact of common perinatal and early childhood antibiotic exposures on the structure and function of the developing gut microbiome. To determine the association between common perinatal and early childhood antibiotic exposures and weight/adiposity gain in a large birth cohort of children. To determine mechanisms for the association between microbiome changes over time and the rate of weight/adiposity gain in a large birth cohort of children. To determine the normal developmental pattern by which healthy children develop antibodies in their blood against the microbes that naturally colonize their intestines. To determine the association between immunostimulation and protection from persistent colonization in humans.

Conditions

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

Obesity, Childhood Antibiotic Side Effect

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

* Born at Pennsylvania Hospital
* Recruited at \<120 hours of age
* Born at ≥36 0/7 weeks gestation
* Birth weight ≥2000 grams
* Parents plan to receive well-child care in the Children's Hospital of Philadelphia (CHOP) network, Society Hill Pediatrics, Center City Pediatrics, Penn Medicine or South Philly Pediatrics
* Biological mother is the legal guardian, or the child is born from a surrogacy with guardianship immediately transferred in hospital

Exclusion Criteria

* Child in neonatal intensive care unit (NICU) for \>120 cumulative hours
* Biological mother NOT legal guardian, except surrogacy where guardianship is transferred at birth
* Biological mother NOT primary caretaker, except surrogacy where guardianship is transferred at birth
* Biological mother \< 18 years of age
* Child has culture confirmed (blood or cerebrospinal fluid cultures) infection
* Biological mother is non-English speaking

Maximum Eligible Age

96 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No