Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers

NCT05467150 | Recruiting

• 1 other identifier: PEDS-2022-29947
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Infant of Diabetic Mother

Keywords

infant of diabetic mother; probiotic; gut microbiome; neurodevelopment

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Probiotic Supplement

EXPERIMENTAL

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

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.

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).

Probiotic Supplement

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Central Study Contacts

Marie Hickey Swanson, MD

CONTACT

612-626-0644; hick0245@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: July 20, 2022
• Study Start: October 17, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

US (1)