Microbiome, Antibiotics, and Growth Infant Cohort (MAGIC)

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Antibiotic Side Effect; Obesity, Childhood

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03001167

15-012623

R01AI121383 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 509 patients

Sex: All

Ages: Under 96 hours old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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