Microbiome, Antibiotics, and Growth Infant Cohort

Completed

• Conditions: Obesity, Childhood; Antibiotic Side Effect

• Registration Number: NCT03001167
• Lead Sponsor: Children's Hospital of Philadelphia

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.

Study Timeline

• Study Start: 2016-12-09
• Study First Submitted: 2016-12-15
• Study First Submitted QC: 2016-12-20
• Study First Posted: 2016-12-22
• Primary Completion: 2021-10-22
• Study Completion: 2023-06-09
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 509

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cumulative microbial diversity	24 months
weight trajectory adjusted for time varying length	24 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States