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Completed

NCT Number: NCT03001167

Microbiome, Antibiotics, and Growth Infant Cohort

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.

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Key information

Age range

Up to 96 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. cumulative microbial diversity

    Time frame: 24 months

  2. weight trajectory adjusted for time varying length

    Time frame: 24 months

Secondary outcomes

  1. total number of individual bacterial taxa

    Time frame: 24 months

  2. expression levels of bacterial gene categories

    Time frame: 24 months

  3. fat stores in the upper arm/extremity

    Time frame: 24 months

    Skinfolds at the triceps are measured (0.1 mm) with a skinfold caliper

  4. fat stores in the upper back/trunk

    Time frame: 24 months

    Skinfolds at the superiliac and subscapular sites are measured (0.1 mm) with a skinfold caliper

  5. supine length trajectory

    Time frame: 24 months

  6. determine the association between immunostimulation and protection from persistent colonization in humans

    Time frame: 24 months

  7. Use autologous serum antibodies to "tag" fecal microbes

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)
  • University of Minnesota
  • University of Pennsylvania

Registry information

Official study title

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

Acronym: MAGIC

Important dates

Study start
2016
Primary completion
2021
Study completion
2023
First posted
Dec 22, 2016
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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