Trials / Recruiting
RecruitingNCT05467150
Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers
Maternal Probiotic Supplementation for Improved Neurodevelopmental Outcomes in Infants of Diabetic Mothers (IDMs)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- University of Minnesota · Academic / Other
- Sex
- Female
- Age
- 21 Years – 45 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2022-10-17
- Primary completion
- 2026-08-31
- Completion
- 2026-08-31
- First posted
- 2022-07-20
- Last updated
- 2025-09-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05467150. Inclusion in this directory is not an endorsement.