Clinical Trial: Pediatric Obesity and the Infant Microbiome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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

Detailed Summary:

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
Sponsor: University of Florida

Current Primary Outcome:

  • Measure bioactive compounds in human milk (HM) via Enzyme-linked immunosorbent assay (ELISA) [ Time Frame: 1 year ]
  • Quantify the infant intestinal gene expression profile in stool by real-time polymerase chain reaction (PCR) [ Time Frame: 1 year ]
  • Measure the infant intestinal gene expression profile in stool via whole genome sequencing (WGS). [ Time Frame: 1 year ]


Original Primary Outcome:

  • Measure bioactive compounds in human milk (HM) via Enzyme-linked immunosorbent assay (ELISA) [ Time Frame: 1 year ]
  • Quantify the infant intestinal gene expression profile in stool by real-time PCR. [ Time Frame: 1 year ]
  • Measure the infant intestinal gene expression profile in stool via whole genome sequencing (WGS). [ Time Frame: 1 year ]


Current Secondary Outcome:

  • Measure Body Mass Index (BMI) in kg/m^2 via the Body Bod instrument. [ Time Frame: 1 year ]
  • Measure weight in kilograms by using a body weight scale. [ Time Frame: 1 year ]
  • Measure height in meters via stadiometer. [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: University of Florida

Dates:
Date Received: July 7, 2016
Date Started: April 28, 2017
Date Completion: August 2034
Last Updated: April 28, 2017
Last Verified: April 2017