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Probiotics for pregnant moms may boost baby brain power

NCT ID NCT05467150

Disease control Sponsor: University of Minnesota Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This study tests whether giving probiotics to pregnant women with diabetes can improve their babies' brain development. Researchers will give 60 mothers a probiotic supplement and then measure their infants' brain responses to sounds and sights at 1 and 6 months old. The goal is to see if the probiotic changes the baby's gut bacteria and helps with memory and attention.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lactobacillus rhamnosus GG (probiotic)
What this could lead to
If it works, this could point toward a simple way to support brain development in babies born to mothers with diabetes.
What could go wrong
This is a small, early-stage study (60 participants) looking at brain wave patterns, not long-term outcomes. Results may not lead to a proven treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

29 people

The number who actually took part.

Started

Oct 2022

Finished

Aug 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

diabetic embryopathy gestational diabetes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infant of diabetic mother

Contacts and locations

Locations

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.