Probiotic supplementation for pregnant women with gestational diabetes to improve infant outcomes
Maternal Probiotic Supplementation for Improved Neurodevelopmental Outcomes in Infants of Diabetic Mothers (IDMs)
This study tests if giving probiotics to pregnant women with gestational diabetes can help improve their babies' brain development and gut health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 21 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05467150 on ClinicalTrials.gov |
What this trial studies
This study investigates whether maternal probiotic supplementation can enhance the gut microbiome and neurodevelopmental outcomes in infants born to mothers with gestational diabetes. The research focuses on infants of diabetic mothers, who are at risk for memory recognition issues. Participants will receive probiotics during the second or third trimester of pregnancy, and outcomes will be measured through infant performance on event-related potentials (ERPs). The study aims to provide insights into the potential benefits of probiotics in this specific population.
Who should consider this trial
Good fit: Ideal candidates are pregnant individuals aged 21-45 with gestational diabetes in their second or third trimester.
Not a fit: Patients who consume alcohol or tobacco during pregnancy or have other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved neurodevelopmental outcomes in infants of diabetic mothers.
How similar studies have performed: While there is emerging interest in the role of probiotics in maternal and infant health, this specific approach targeting infants of diabetic mothers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Marie Hickey Swanson, MD
- Email: hick0245@umn.edu
- Phone: 612-626-0644
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.