Pediatric Obesity
Conditions
Keywords
Breastfeeding, Microbiome, BEACH, Human milk, Pediatric Obesity
Brief summary
The impact of breastfeeding on the infant microbiome in vaginally and Cesarean delivered offspring from obese and normal weight mothers.
Detailed 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).
Interventions
None listed
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Florida
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Between the ages of 18 and 45 years of age. * Pre-pregnancy BMI is greater than 30 kg/m2 * Pre-pregnancy BMI is less than 25 kg/m2 * At risk for gestational diabetes * Pregnant and have Type 1 diabetes (T1D) * Pregnant and have Type 2 diabetes (T2D) * pregnant and within the 3rd trimester (34-36 weeks of gestation)-You plan to deliver in the Greater Gainesville area * Plan to deliver via vaginal or cesarean section * Plan to exclusively breastfeed your infant for at least 2 months * Child will receive their pediatric care through UFHealth
Exclusion criteria
* Smoking * Pre-eclampsia * History of pre-term delivery (\<35 weeks) * Only one breast capable of lactation and milk production inadequate * Age \<18 yrs, \>45 yrs * Any maternal antibiotics in the last 2 weeks during delivery * Any alcohol consumption * Drug use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure the infant intestinal gene expression profile in stool via whole genome sequencing (WGS). | 1 year |
| Measure bioactive compounds in human milk (HM) via Enzyme-linked immunosorbent assay (ELISA) | 1 year |
| Quantify the infant intestinal gene expression profile in stool by real-time polymerase chain reaction (PCR) | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Measure height in meters via stadiometer. | 1 year |
| Measure Body Mass Index (BMI) in kg/m^2 via the Body Bod instrument. | 1 year |
| Measure weight in kilograms by using a body weight scale. | 1 year |
Other
| Measure | Time frame |
|---|---|
| Measure infant body composition by using anthropometry. | 1 year |
Countries
United States
Outcome results
None listed