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Pediatric Obesity and the Infant Microbiome (BEACH) — BEACH  

Pediatric Obesity Clinical Trial

Official title:
The Breastfeeding and Early Child Health (BEACH) Study

Clinical Trial Summary

The impact of breastfeeding on the infant microbiome in vaginally and Cesarean delivered offspring from obese and normal weight mothers.

Clinical Trial Description

Design: Normal weight (NW; pre-pregnant BMI <25.0 kg/m2), obese (Ob; pre-pregnant BMI >30.0 kg/m2), gestational diabetes (GDM), Type 2 diabetes (T2D), and Type 1 diabetes mothers during the 3rd trimester (34-36 weeks) of pregnancy that will be followed -along with their respective offspring- through the first 12 months of life will be recruited from the University of Florida (UF) Health Shands Hospital. Stool, saliva, blood, vaginal swab, human milk, urine, body composition and clinical variables will be collected from mother and infant at 34-36 weeks of gestation (mom only), 2-weeks, 2-months, and 1-year at the UF Clinical Research Center. Infant body composition is the primary outcome and will be monitored via anthropometry. Follow-up data points will be collected from electronic health records (EHR) and include but are not limited to wellness visits by 1 month, 2 months, 4 months, 6 months, 9 months, 12 months, 15 months, 18 months, 2 years, 2 ½ years, 3 years, and each year after that until 17.9 years. Planned data analysis includes linear regression using the R statistical program. The primary data analysis will test maternal health status and human milk bioactive components for associations with the infant microbiome and pediatric outcomes collected by clinical visits and EHR. The study team will recruit equal samples of pregnant mothers in each the following groups (n=50 in each group; 1800 total participants): 1) NW vaginal deliveries; 2) NW C-section deliveries; 3) Ob vaginal deliveries 4) Ob C-section deliveries; 5) GDM vaginal deliveries; 6) GDM C-section deliveries; 7) T2D vaginal deliveries; 8) T2D C-section deliveries; 9) T1D vaginal deliveries; 10) T1D C-section deliveries. Stool, saliva, and vaginal swab samples collected from participants may be used for animal studies whereby germ-free mice are inoculated with stool samples to evaluate a causal role of the microbiome in clinically relevant phenotypes (i.e. pediatric obesity). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02843087
Study type Observational
Source University of Florida
Contact Magda Francois
Phone 813-627-9471
Email magdafrancois@ufl.edu
Status Recruiting
Phase
Start date April 28, 2017
Completion date August 2034
View Details
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