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NCT Number: NCT05467150

Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers

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.

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Key information

Conditions

Infant of Diabetic Mother

Age range

21 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Marie Hickey Swanson, MD

CONTACT

[email protected]

612-626-0644

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Infant auditory recognition ERP performance at 1 month: P200 amplitude

    Time frame: 1 month of age

    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.

  2. Infant auditory recognition ERP performance at 1 month: Negative slow wave difference score

    Time frame: 1 month of age

    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).

  3. Infant visual recognition ERP performance at 6 months: Slow wave difference score

    Time frame: 6 months of age

    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.

  4. Infant VEP performance at 6 months: latency to peak of P100

    Time frame: 6 months of age

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marie Hickey Swanson, MD

CONTACT

[email protected]

612-626-0644

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2022
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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