Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers
Maternal Probiotic Supplementation for Improved Neurodevelopmental Outcomes in Infants of Diabetic Mothers (IDMs)
University of Minnesota
60 participants
Oct 17, 2022
INTERVENTIONAL
Summary
The purpose of this study is to test the hypothesis that maternal probiotic supplementation is associated with infant gut microbiome variation and improved neurodevelopmental outcomes as measured by ERP performance in infants of diabetic mothers (IDMs), a cohort that is at-risk for recognition memory abnormalities.
Eligibility
Inclusion Criteria5
- Pregnant people in their second or third trimester with a diagnosis of gestational diabetes.
- BMI 18.5-45 kg/m2 at first prenatal visit
- Age 21-45 at time of delivery
- Report social support for and intention to exclusively breastfeed for at least 3 months
- Singleton pregnancy
Exclusion Criteria6
- Alcohol consumption >1 drink per week during pregnancy/lactation
- Tobacco consumption during pregnancy/lactation
- Inability to speak/understand English
- Known congenital metabolic, endocrine disease (other than GDM), or congenital illness affecting infant feeding
- History of type I Diabetes
- Birthing parent currently taking over the counter probiotic preparation
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Interventions
The probiotic that will be used is Culturelle® Digestive Daily Probiotic Capsules. Each capsule contains 10 billion CFU of Lactobacillus rhamnosus GG (LGG).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05467150