Actively Recruiting

Phase Not Applicable
Age: 21Years - 45Years
FEMALE
NCT05467150

Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers

Led by University of Minnesota · Updated on 2025-09-12

60

Participants Needed

1

Research Sites

202 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers

Who Can Participate

Age: 21Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant people in their second or third trimester with a diagnosis of gestational diabetes
  • BMI between 18.5 and 45 kg/m2 at first prenatal visit
  • Age between 21 and 45 years at time of delivery
  • Report social support for and intention to exclusively breastfeed for at least 3 months
  • Singleton pregnancy
Not Eligible

You will not qualify if you...

  • Alcohol consumption more than 1 drink per week during pregnancy or lactation
  • Tobacco use during pregnancy or lactation
  • Inability to speak or understand English
  • Known congenital metabolic or endocrine disease (other than gestational diabetes), or congenital illness affecting infant feeding
  • History of type I Diabetes
  • Currently taking over the counter probiotic preparations

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

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Research Team

M

Marie Hickey Swanson, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers | DecenTrialz