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Could a simple supplement protect Kids' guts during heart surgery?

NCT ID NCT06882772

Disease control Sponsor: University of Nebraska 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a butyric acid supplement, taken daily for three weeks before heart surgery, can safely improve gut health and reduce inflammation in infants and young children (ages 1 month to 3 years) with congenital heart disease. Researchers will monitor side effects, changes in gut bacteria, and markers of inflammation. The trial aims to see if this simple approach can help kids recover better after surgery.

What this could mean

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

Active substance
Butyric acid (SunButyrate-TG)
What this could lead to
If it works, this could point toward a simple, safe way to improve gut health and reduce inflammation in young children after heart surgery.
What could go wrong
This is an early phase 2a trial with only 105 participants, so results may not be conclusive. The supplement may cause side effects like vomiting or diarrhea, and it might not improve outcomes as hoped.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 105 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

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

1 month to 3 years

Sex

Anyone

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: * Infants and Children undergoing cardiac surgery with cardiopulmonary bypass Exclusion Criteria: * Antibiotics, surgery, or chemotherapy within the past 8 weeks * Continuous enteral feeds before surgery * GI pathology or intestinal surgery (excluding G-tube) * Liver disease with elevated transaminitis or dialysis-dependent renal disease

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Conditions

The condition(s) this trial relates to.

congenital heart disease Inflammation

As listed by the trial registrant

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

Congenital heart disease (CHD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Nebraska, 8200 Dodge St

    Omaha, Nebraska, 68114, United States

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