Microbiome, Antibiotics, and Growth Infant Cohort (MAGIC)

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Childhood; Antibiotic Side Effect

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.

• Study Type: Observational
• Enrollment (Actual): 509

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 days (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Our study population will be comprised of children born at Pennsylvania Hospital between 2016-2018 and subsequently, followed in the Children's Hospital of Philadelphia (CHOP) Care Network or one of four other local primary care pediatric practices.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cumulative microbial diversity	24 months
weight trajectory adjusted for time varying length	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total number of individual bacterial taxa		24 months
expression levels of bacterial gene categories		24 months
fat stores in the upper arm/extremity	Skinfolds at the triceps are measured (0.1 mm) with a skinfold caliper	24 months
fat stores in the upper back/trunk	Skinfolds at the superiliac and subscapular sites are measured (0.1 mm) with a skinfold caliper	24 months
supine length trajectory		24 months
determine the association between immunostimulation and protection from persistent colonization in humans		24 months
Use autologous serum antibodies to "tag" fecal microbes		24 months

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); University of Pennsylvania; University of Minnesota
• Investigators: Principal Investigator: Dan Knights, PhD, University of Minnesota; Principal Investigator: Jeffrey S Gerber, MD, PhD, Children's Hospital of Philadelphia

Publications and helpful links

Helpful Links

• Official study website

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2016
• Primary Completion (Actual): October 22, 2021
• Study Completion (Actual): June 9, 2023

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: December 20, 2016
• First Posted (Estimated): December 22, 2016

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Microbiome; Antibiotics; Growth
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 15-012623; R01AI121383 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified individual participant data will be shared with collaborators at the Knights Lab at the University of Minnesota.