Pediatric Obesity and the Infant Microbiome (BEACH)
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 2/28/2019 |
| Start Date: | April 28, 2017 |
| End Date: | August 2034 |
| Contact: | Magda Francois |
| Email: | magdafrancois@ufl.edu |
| Phone: | 813-627-9471 |
The Breastfeeding and Early Child Health (BEACH) Study
The impact of breastfeeding on the infant microbiome in vaginally and Cesarean delivered
offspring from obese and normal weight mothers.
offspring from obese and normal weight mothers.
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).
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).
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
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