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New treatment option for Infant of Diabetic Mother
Official title Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers
ClinicalTrials.gov ID: NCT05467150
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 45, women only
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 21 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.