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Clinical Trials/NCT03001167
NCT03001167
Completed
Not Applicable

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

Children's Hospital of Philadelphia1 site in 1 country509 target enrollmentDecember 9, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity, Childhood
Sponsor
Children's Hospital of Philadelphia
Enrollment
509
Locations
1
Primary Endpoint
cumulative microbial diversity
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 9, 2016
End Date
June 9, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

cumulative microbial diversity

Time Frame: 24 months

weight trajectory adjusted for time varying length

Time Frame: 24 months

Secondary Outcomes

  • fat stores in the upper arm/extremity(24 months)
  • Use autologous serum antibodies to "tag" fecal microbes(24 months)
  • fat stores in the upper back/trunk(24 months)
  • total number of individual bacterial taxa(24 months)
  • supine length trajectory(24 months)
  • expression levels of bacterial gene categories(24 months)
  • determine the association between immunostimulation and protection from persistent colonization in humans(24 months)

Study Sites (1)

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