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Microbiome, Antibiotics, and Growth Infant Cohort

Early Life Antibiotics, Gut Microbiome Development, and Risk of Childhood Obesity

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03001167
Acronym
MAGIC
Enrollment
509
Registered
2016-12-22
Start date
2016-12-09
Completion date
2023-06-09
Last updated
2024-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Side Effect, Obesity, Childhood

Keywords

Microbiome, Antibiotics, Growth

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

University of Minnesota
CollaboratorOTHER
University of Pennsylvania
CollaboratorOTHER
National Institute of Allergy and Infectious Diseases (NIAID)
CollaboratorNIH
Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 96 Hours
Healthy volunteers
No

Inclusion criteria

(if not specified, applies to child): * 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

(if not specified, applies to child): * 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

Design outcomes

Primary

MeasureTime frame
cumulative microbial diversity24 months
weight trajectory adjusted for time varying length24 months

Secondary

MeasureTime frameDescription
fat stores in the upper arm/extremity24 monthsSkinfolds at the triceps are measured (0.1 mm) with a skinfold caliper
fat stores in the upper back/trunk24 monthsSkinfolds at the superiliac and subscapular sites are measured (0.1 mm) with a skinfold caliper
total number of individual bacterial taxa24 months
determine the association between immunostimulation and protection from persistent colonization in humans24 months
Use autologous serum antibodies to tag fecal microbes24 months
supine length trajectory24 months
expression levels of bacterial gene categories24 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026