Pediatric Obesity and the Infant Microbiome (BEACH) (BEACH)

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Obesity

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).

• Study Type: Observational
• Enrollment (Estimated): 1700

Contacts and Locations

• Study Contact: Name: Magda Francois; Phone Number: 813-627-9471; Email: magdafrancois@ufl.edu
• Study Contact Backup: Name: Dominick J Lemas, PhD; Phone Number: 3522945971; Email: djlemas@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Recruiting
      • University of Florida
      • Contact: Olivia Carney, MS; Phone Number: 352-294-8361; Email: ocarney1@ufl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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.

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

10

Cohorts and Interventions

Group / Cohort
NW vaginal deliveries; 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.
NW C-section deliveries; 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.
Ob vaginal deliveries; 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.
Ob C-section deliveries; 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.
GDM vaginal deliveries; 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.
GDM C-section deliveries; 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.
T2D vaginal deliveries; 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.
T2D C-section deliveries; 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.
T1D vaginal deliveries; 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.
T1D C-section deliveries; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Measure the infant intestinal gene expression profile in stool via whole genome sequencing (WGS).	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Measure height in meters via stadiometer.	1 year

Other Outcome Measures

Outcome Measure	Time Frame
Measure infant body composition by using anthropometry.	1 year

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Dominick J Lemas, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2017
• Primary Completion (Estimated): August 1, 2034
• Study Completion (Estimated): August 1, 2034

Study Registration Dates

• First Submitted: July 7, 2016
• First Submitted That Met QC Criteria: July 20, 2016
• First Posted (Estimated): July 25, 2016

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Microbiome; Breastfeeding; Pediatric Obesity; Human milk; BEACH
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: IRB201601034; OCR16157 (Other Identifier: University of Florida); 1K01DK115632-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with the NIH Data Sharing Policy of award 1U24DK097193, all data generated by Southeast Center for Integrated Metabolomics (SECIM), along with the corresponding metadata, will be deposited into the NIH Metabolomics Data Repository and Coordinating Center (DRCC) as soon as all quality control steps are completed. Data will be embargoed for one year and, after the expiration of the embargo, made visible to the scientific community regardless of publication status for the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No