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Probiotic

Probiotic Supplementation for Infants of Diabetic Mothers

N/A

Recruiting

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 21-45 at time of delivery

Pregnant people in their second or third trimester with a diagnosis of gestational diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months of age

Awards & highlights

Study Summary

This trial is testing whether probiotics improve gut health and neurodevelopment in infants of mothers with diabetes.

Who is the study for?

This trial is for pregnant individuals aged 21-45 with a BMI of 18.5-45 kg/m2, diagnosed with gestational diabetes, and planning to exclusively breastfeed for at least three months. It's not for those who smoke or drink alcohol during pregnancy/lactation, have type I Diabetes, other metabolic/endocrine diseases affecting infant feeding, or are already taking probiotics.Check my eligibility

What is being tested?

The study is examining if taking probiotic supplements during pregnancy can influence the baby's gut bacteria and improve brain development outcomes in infants born to diabetic mothers.See study design

What are the potential side effects?

Probiotic supplements are generally considered safe but may cause digestive discomfort such as gas or bloating. Specific side effects related to this trial haven't been listed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 21 and 45 years old.

Select...

I am in my second or third trimester and have been diagnosed with gestational diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months of age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months of age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months of age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Infant VEP performance at 6 months: latency to peak of P100

Infant auditory recognition ERP performance at 1 month: Negative slow wave difference score

Infant auditory recognition ERP performance at 1 month: P200 amplitude

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Probiotic SupplementExperimental Treatment1 Intervention

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

Group II: No interventionActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Probiotic Supplement

2006

N/A

~180

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,378 Previous Clinical Trials

1,588,449 Total Patients Enrolled

Media Library

Probiotic Supplement (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05467150 — N/A

Infants of Diabetic Mothers Research Study Groups: Probiotic Supplement, No intervention

Infants of Diabetic Mothers Clinical Trial 2023: Probiotic Supplement Highlights & Side Effects. Trial Name: NCT05467150 — N/A

Probiotic Supplement (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05467150 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study restrict participation to those below a certain age?

"This research trial is restricted to adults aged between 21 and 45 years old."

Answered by AI

How many trial participants are there in total?

"Affirmative. According to clinicaltrials.gov, this medical experiment is currently recruiting participants after first being posted on October 17th 2022 and subsequently edited on November 18th 2022. The trial requires 60 patients from a single site for enrollment."

Answered by AI

Do I qualify to partake in this clinical trial?

"This clinical trial will accept 60 pregnant women with diabetes between 21 and 45 years old. Aspiring participants must have a BMI of 18.5-45 kg/m2, be in their second or third trimester, possess social support for exclusive breastfeeding for 3 months minimum, and they must not have multiple pregnancies."

Answered by AI

Are any participants currently being sought for this investigation?

"Affirmative. According to the clinicaltrials.gov website, this clinical trial is actively enrolling participants. It was first announced on October 17th 2022 and has had its most recent update on November 18th 2022. The study needs 60 patients from 1 medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers

2022. "Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05467150.