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Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Enrolling

Conditions

Infant of Diabetic Mother

Treatments

Dietary Supplement: Probiotic Supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT05467150
PEDS-2022-29947

Details and patient eligibility

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.

Enrollment

60 estimated patients

Sex

Female

Ages

21 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Probiotic Supplement
Experimental group
Description:
Participants (mothers) randomized to this arm will take one Culturelle® Digestive Daily Probiotic Capsule per day from study enrollment through the first postpartum month. Each capsule contains 10 billion CFU of Lactobacillus rhamnosus GG
Treatment:
Dietary Supplement: Probiotic Supplement
No intervention
No Intervention group
Description:
Participants (mothers) randomized to this arm will agree to continue not taking any over the counter probiotic supplements from study enrollment through the first postpartum month.

Trial contacts and locations

1

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Central trial contact

Marie Hickey Swanson, MD

Data sourced from clinicaltrials.gov

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