Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers

Study Overview
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Brief Summary
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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.

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

Conditions
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Infant of Diabetic Mother

Intervention / Treatment
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* Dietary Supplement: Probiotic Supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic Supplement<br>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<br>* The probiotic that will be used is Culturelle® Digestive Daily Probiotic Capsules. Each capsule contains 10 billion CFU of Lactobacillus rhamnosus GG (LGG).<br>|
| No Intervention: No intervention<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant of diabetic mother, probiotic, gut microbiome, neurodevelopment