Status:
COMPLETED
Prenatal Probiotic Intervention
Lead Sponsor:
Arkansas Children's Hospital Research Institute
Conditions:
Childhood Obesity
Maternal Obesity During Childbirth
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study will assess the feasibility of a randomized control trial in which the effects of probiotic supplementation throughout pregnancy on maternal insulin sensitivity and inflammation, as well of...
Detailed Description
Maternal obesity leads to increased insulin resistance and inflammation which have been shown to induce fetal adaptations and greater risk of obesity in the offspring. Probiotic supplementation during...
Eligibility Criteria
Inclusion
- BMI ≥ 30
- ≥ 18 years of age
- Singleton pregnancy
- Less than 12 weeks of gestation
- Less than 1 serving of yoghurt with live cultures or cultured milk per week
- Conceived without assisted fertility treatments
Exclusion
- • Women with pre-existing medical conditions (e.g., diabetes, hypertension, thyroid disorders, heart disease or immune disorders) as determined by the PI to affect the outcomes of interest
- Immunosuppressed women
- Women taking medications during pregnancy known to affect fetal growth (i.e., thyroid hormone, glucocorticoids, insulin, oral hypoglycemic agents)
- Women who are using recreational drugs, tobacco or alcohol during their pregnancy
- Milk intolerance or allergy
- Consuming probiotic supplements
Key Trial Info
Start Date :
August 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03240419
Start Date
August 23 2017
End Date
March 26 2019
Last Update
January 18 2022
Active Locations (1)
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1
Arkansas Children's Nutrition Center
Little Rock, Arkansas, United States, 72202