Microbiome, Antibiotics, and Growth Infant Cohort

Study 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.

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

Conditions
-----------------
Obesity, Childhood, Antibiotic Side Effect

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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: Child in neonatal intensive care unit (NICU) for ≥ 120 cumulative hours Biological mother NOT legal guardian Biological mother NOT primary caretaker Biological mother < 18 years of age Child has culture confirmed-infection Biological mother is non-English speaking

Ages Eligible for Study
-----------------
Maximum Age: 96 Hours

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microbiome, Antibiotics, Growth