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Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers

Primary Purpose

Infant of Diabetic Mother

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Probiotic Supplement
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant of Diabetic Mother focused on measuring infant of diabetic mother, probiotic, gut microbiome, neurodevelopment

Eligibility Criteria

21 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Probiotic Supplement

No intervention

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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).
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 16, 2022
Last Updated
November 18, 2022
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05467150
Brief Title
Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers
Official Title
Maternal Probiotic Supplementation for Improved Neurodevelopmental Outcomes in Infants of Diabetic Mothers (IDMs)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant of Diabetic Mother
Keywords
infant of diabetic mother, probiotic, gut microbiome, neurodevelopment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic Supplement
Arm Type
Experimental
Arm Description
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
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic Supplement
Intervention Description
The probiotic that will be used is Culturelle® Digestive Daily Probiotic Capsules. Each capsule contains 10 billion CFU of Lactobacillus rhamnosus GG (LGG).
Primary Outcome Measure Information:
Title
Infant auditory recognition ERP performance at 1 month: P200 amplitude
Description
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
Title
Infant auditory recognition ERP performance at 1 month: Negative slow wave difference score
Description
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
Title
Infant visual recognition ERP performance at 6 months: Slow wave difference score
Description
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
Title
Infant VEP performance at 6 months: latency to peak of P100
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Hickey Swanson, MD
Phone
612-626-0644
Email
hick0245@umn.edu
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Hickey Swanson, MD
Phone
612-626-0644
Email
hick0245@umn.edu

12. IPD Sharing Statement

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Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers

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