Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers

Infant of Diabetic Mother Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05467150
• Other study ID #: PEDS-2022-29947
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: December 2023
• Source: University of Minnesota
• Contact: Marie Hickey Swanson, MD
• Phone: 612-626-0644
• Email: hick0245[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infant of Diabetic Mother
• Pregnancy in Diabetics

Intervention

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).

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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