Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers
NCT ID: NCT05467150
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2022-10-17
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Probiotic Supplement
Participants (mothers) randomized to this arm will take one Culturelle® Digestive Daily Probiotic Capsule per day from study enrollment through the first postpartum month. Each capsule contains 10 billion CFU of Lactobacillus rhamnosus GG
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).
No intervention
Participants (mothers) randomized to this arm will agree to continue not taking any over the counter probiotic supplements from study enrollment through the first postpartum month.
No interventions assigned to this group
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
45 Years
FEMALE
No
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PEDS-2022-29947
Identifier Type: -
Identifier Source: org_study_id
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