Pediatric Obesity and the Infant Microbiome (BEACH)

Pediatric Obesity Clinical Trial

— BEACH  

Official title:

The Breastfeeding and Early Child Health (BEACH) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02843087
• Other study ID #: IRB201601034
• Secondary ID: OCR161571K01DK11
• Status: Recruiting
• Start date: April 28, 2017
• Est. completion date: August 2034

Study information

• Verified date: May 2023
• Source: University of Florida
• Contact: Magda Francois
• Phone: 813-627-9471
• Email: magdafrancois[@]ufl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1700
• Est. completion date: August 2034
• Est. primary completion date: August 2034
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measure infant body composition by using anthropometry.		1 year
Primary	Measure bioactive compounds in human milk (HM) via Enzyme-linked immunosorbent assay (ELISA)		1 year
Primary	Quantify the infant intestinal gene expression profile in stool by real-time polymerase chain reaction (PCR)		1 year
Primary	Measure the infant intestinal gene expression profile in stool via whole genome sequencing (WGS).		1 year
Secondary	Measure Body Mass Index (BMI) in kg/m^2 via the Body Bod instrument.		1 year
Secondary	Measure weight in kilograms by using a body weight scale.		1 year
Secondary	Measure height in meters via stadiometer.		1 year