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Sugar-Digesting enzyme trial for short gut patients ends early

NCT ID NCT04604275

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested whether giving sucrase, an enzyme that breaks down sugar, could help people with short bowel syndrome and intestinal failure digest sugar better. The goal was to reduce symptoms like bloating, pain, and diarrhea, and help them tolerate more food. However, the trial was terminated early and only enrolled 3 participants, so the results are very limited.

What this could mean

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

Active substance
sucrase (an enzyme that helps digest sugar)
What this could lead to
If it works, this could help short bowel syndrome patients tolerate more food by mouth or feeding tube, reducing uncomfortable symptoms like bloating and diarrhea.
What could go wrong
This was a very small, early-phase trial that was terminated after enrolling only 3 people, so we have very little data. It is unclear if the enzyme is effective or safe in this group.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

3 people

The number who actually took part.

Started

Jan 2022

Finished

Sep 2024

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Short bowel syndrome, of all ages, with dependence on parental support to provide at least 50% of fluid or caloric needs. * Must be on diet containing sucrose. * Must be willing and able to sign informed consent * Adult and Pediatric patients (all ages) Exclusion Criteria: * Current IV antibiotic administration for confirmed bout of bacteremia. * No enteral nutrition * Any condition, disease, illness, or circumstance that in the investigator's opinion puts the subject at any undue risk, prevents completion of the study, or interferes with analysis of the study results

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Conditions

The condition(s) this trial relates to.

Intestinal Failure short bowel syndrome

As listed by the trial registrant

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

Contacts and locations

Locations

  • Jackson Memorial Hospital

    Miami, Florida, 33136, United States

  • University of Miami

    Miami, Florida, 33136, United States

More trials for these conditions

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