Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers

Recruiting now · Not applicable

Conditions studied: Infant of Diabetic Mother

In brief

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.

Key facts

Study ID

NCT05467150

Run by

University of Minnesota

People needed

60

Starts

2022-10-17

Expected to finish

2026-08-31

Last updated by the study team

2025-09-12

Who can join

Age: 21 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.