RECRUITING

Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Maternal Probiotic Supplementation for Improved Neurodevelopmental Outcomes in Infants of Diabetic Mothers (IDMs)

Quick Facts

Study Start:2022-10-17
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05467150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant people in their second or third trimester with a diagnosis of gestational diabetes.
  2. * BMI 18.5-45 kg/m2 at first prenatal visit
  3. * Age 21-45 at time of delivery
  4. * Report social support for and intention to exclusively breastfeed for at least 3 months
  5. * Singleton pregnancy
  1. * Alcohol consumption \>1 drink per week during pregnancy/lactation
  2. * Tobacco consumption during pregnancy/lactation
  3. * Inability to speak/understand English
  4. * Known congenital metabolic, endocrine disease (other than GDM), or congenital illness affecting infant feeding
  5. * History of type I Diabetes
  6. * Birthing parent currently taking over the counter probiotic preparation

Contacts and Locations

Study Contact

Marie Hickey Swanson, MD
CONTACT
612-626-0644
hick0245@umn.edu

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-17
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2022-10-17
Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

  • infant of diabetic mother
  • probiotic
  • gut microbiome
  • neurodevelopment

Additional Relevant MeSH Terms

  • Infant of Diabetic Mother