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(352) 733-0111

BEACH

  • Status
    Accepting Candidates
  • Age
    18 Years - 45 Years
  • Sexes
    Female
  • Healthy Volunteers
    Accepts Healthy Volunteers
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Objective

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 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;

  1. 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).

Details

Full study title The Breastfeeding and Early Child Health
Protocol number OCR16157
ClinicalTrials.gov ID NCT02843087

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 (

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

    Dominick Lemas
  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.