Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers

Conditions

• Infant of Diabetic Mother

Eligibility Criteria

Sex

FEMALE

Age

21 Years - 45 Years

Healthy Volunteers

Not accepted

Interventions

• Probiotic Supplement — DIETARY_SUPPLEMENT
  The probiotic that will be used is Culturelle® Digestive Daily Probiotic Capsules. Each capsule contains 10 billion CFU of Lactobacillus rhamnosus GG (LGG).

Study Details

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 Dates

Start date

Oct 17, 2022

Status verified

Sep 2025

Primary completion

Aug 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Probiotic Supplement
  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
• No Intervention: No intervention
  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.

Primary Outcome Measure

Infant auditory recognition ERP performance at 1 month: P200 amplitude [ Time Frame: 1 month of age ]

Central Contacts

• Marie Hickey Swanson, MD
  612-626-0644
  [email protected]

Locations (1)

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