Microbiome, Antibiotics, and Growth Infant Cohort

Obesity, Childhood Clinical Trial

— MAGIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03001167
• Other study ID #: 15-012623
• Secondary ID: R01AI121383
• Status: Completed
• Start date: December 9, 2016
• Est. completion date: June 9, 2023

Study information

• Verified date: January 2024
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: June 9, 2023
• Est. primary completion date: October 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 96 Hours

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Side Effect
• Obesity
• Obesity, Childhood
• Pediatric Obesity

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Institute of Allergy and Infectious Diseases (NIAID), University of Minnesota, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative microbial diversity		24 months
Primary	weight trajectory adjusted for time varying length		24 months
Secondary	total number of individual bacterial taxa		24 months
Secondary	expression levels of bacterial gene categories		24 months
Secondary	fat stores in the upper arm/extremity	Skinfolds at the triceps are measured (0.1 mm) with a skinfold caliper	24 months
Secondary	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
Secondary	supine length trajectory		24 months
Secondary	determine the association between immunostimulation and protection from persistent colonization in humans		24 months
Secondary	Use autologous serum antibodies to "tag" fecal microbes		24 months

External Links

•   Official study website