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Recruiting NCT05467150

Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers

Trial Parameters

Condition Infant of Diabetic Mother
Sponsor University of Minnesota
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex FEMALE
Min Age 21 Years
Max Age 45 Years
Start Date 2022-10-17
Completion 2026-08-31
Interventions
Probiotic Supplement

Brief 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 Criteria

Inclusion Criteria: * 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 Criteria: * 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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