Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers

University of Minnesota60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infant of Diabetic Mother

Interventions

Probiotic SupplementDIETARY_SUPPLEMENT

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

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 6 months of age

Central Contacts

Marie Hickey Swanson, MD

CONTACT

612-626-0644 hick0245@umn.edu

Data from ClinicalTrials.gov

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