Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotic Supplement.
- Who it may be relevant to
- Registry conditions: Infant of Diabetic Mother. Basic parameters: 21 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Maternal Probiotic Supplementation for Improved Neurodevelopmental Outcomes in Infants of Diabetic Mothers (IDMs)
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.
Interventions
- 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).
Primary outcome measures
- Infant auditory recognition ERP performance at 1 month: P200 amplitude [Time frame: 1 month of age]
- Infant auditory recognition ERP performance at 1 month: Negative slow wave difference score [Time frame: 1 month of age]
- Infant visual recognition ERP performance at 6 months: Slow wave difference score [Time frame: 6 months of age]
- Infant VEP performance at 6 months: latency to peak of P100 [Time frame: 6 months of age]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT05467150 · PEDS-2022-29947