Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers

Maternal Probiotic Supplementation for Improved Neurodevelopmental Outcomes in Infants of Diabetic Mothers (IDMs)

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.

Study Overview

• Status: Recruiting
• Conditions: Infant of Diabetic Mother
• Intervention / Treatment: Dietary supplement: Probiotic Supplement

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie Hickey Swanson, MD; Phone Number: 612-626-0644; Email: hick0245@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Marie Hickey Swanson, MD; Phone Number: 612-626-0644; Email: hick0245@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 41 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Dietary supplement: Probiotic Supplement; The probiotic that will be used is Culturelle® Digestive Daily Probiotic Capsules. Each capsule contains 10 billion CFU of Lactobacillus rhamnosus GG (LGG).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant auditory recognition ERP performance at 1 month: P200 amplitude	At one month of age, an auditory recognition memory ERP will be performed. Components of interest will be the P200 amplitude (in microvolts) The P200 is a positive component of the ERP waveform and a measure of early perceptual processing of stimuli.	1 month of age
Infant auditory recognition ERP performance at 1 month: Negative slow wave difference score	At one month of age, an auditory recognition memory ERP will be performed. Components of interest will be latency in milliseconds. The area under the curve of the negative slow wave (NSW, a late slow-resolving component if the ERP waveform, which is thought to index detection of a novel stimulus against the background of familiar stimuli).	1 month of age
Infant visual recognition ERP performance at 6 months: Slow wave difference score	At 6 months of age, visual-evoked potential ERP paradigms will be performed. We will be measuring the latency and amplitude of the N290, a negative component occurring between 150-400ms (representing face processing), the amplitude of the negative central (NC) component, occurring between 350-700ms and thought to index attention, and the area under the curve of the slow-resolving positive component occurring between 900-1500ms that indexes memory updating.	6 months of age
Infant VEP performance at 6 months: latency to peak of P100	The main component of interest in the VEP waveform is a large positive wave peaking at about 100 ms (P100). We will be looking at the latency to the peak of the P100 component (milliseconds) as a measure of speed of processing.	6 months of age

Collaborators and Investigators

• Sponsor: University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: probiotic; gut microbiome; neurodevelopment; infant of diabetic mother
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Pregnancy in Diabetics; Fetal Diseases
• Other Study ID Numbers: PEDS-2022-29947

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No