Clinical trial NCT02843087: Pediatric Obesity and the Infant Microbiome (BEACH)
Official title: The Breastfeeding and Early Child Health (BEACH) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Obesity
Keywords: Breastfeeding
Microbiome
BEACH
Human milk
Pediatric Obesity
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-07-25
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Measure bioactive compounds in human milk (HM) via Enzyme-linked immunosorbent assay (ELISA)
timeFrame: 1 year
measure: Quantify the infant intestinal gene expression profile in stool by real-time polymerase chain reaction (PCR)
timeFrame: 1 year
measure: Measure the infant intestinal gene expression profile in stool via whole genome sequencing (WGS).
timeFrame: 1 year
Secondary outcomes:
measure: Measure Body Mass Index (BMI) in kg/m^2 via the Body Bod instrument.
timeFrame: 1 year
measure: Measure weight in kilograms by using a body weight scale.
timeFrame: 1 year
measure: Measure height in meters via stadiometer.
timeFrame: 1 year
Other outcomes:
measure: Measure infant body composition by using anthropometry.
timeFrame: 1 year
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Dominick J Lemas, PhD
role: PRINCIPAL_INVESTIGATOR
References: