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Sugar compound aimed at saving tiny guts: trial pulled before start

NCT ID NCT06547424

Disease control Sponsor: Indiana University 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study was designed to test whether a supplement called chondroitin sulfate is safe for newborns with necrotizing enterocolitis (NEC), a severe gut infection. The plan was to give the supplement to very low birth weight babies for two days and compare their outcomes to those receiving a placebo. However, the trial was withdrawn before any babies were enrolled, so no results are available.

What this could mean

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

Active substance
chondroitin sulfate
What this could lead to
If successful, this could point toward a safe way to reduce surgery and improve outcomes in babies with NEC.
What could go wrong
The trial was withdrawn before any patients were enrolled, so no data exists. It is a very early phase 1 safety study, and benefits are uncertain.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Expected to start

Jan 2025

An estimate. Start dates often move.

Expected to finish

Mar 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 hour to 6 months

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: 1. NICU patient at Riley Hospital for Children 2. Weight of less than 2500g at time of NEC diagnosis 3. Patient must have a diagnosis of Bell's Stage 2 necrotizing enterocolitis Exclusion Criteria: 1. Severe cardiac or neurological congenital anomalies 2. Previous history of NEC 3. History of abdominal surgery or other intestinal congenital anomalies 4. Renal failure or renal impairment necessitating dialysis 5. Any end-stage organ disease, infection, or condition, which in the opinion of the Investigator, makes the patient an unsuitable candidate for treatment 6. Receipt of another investigational therapy 7. Informed consent is unable to be obtained from parent or legally authorized representative 8. Patient is a ward of the court system

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Conditions

The condition(s) this trial relates to.

acute intestinal ischemia ischemic bowel disorder necrotizing enterocolitis

As listed by the trial registrant

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

Intestinal ischemia Necrotizing enterocolitis

Contacts and locations

Locations

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202, United States

More trials for these conditions

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