NCT05467150NARecruiting

Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers

University of Minnesota

Start Date

10/17/2022

Completion Date

8/31/2026

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

Age Range: 21 years to 45 years

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

Interventions

DIETARY_SUPPLEMENT

Probiotic Supplement

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Conditions

Infant of Diabetic Mother

Locations

University of Minnesota

Minneapolis, Minnesota 55455

United States