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NCT04604275 · ClinicalTrials.gov registry record · Phase 2
Functional Sucrase Deficiency in Short Bowel Syndrome Patients With Intestinal Failure
A Phase 2 study, sponsored by University of Miami.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT04604275: Clinical Trial Phase 2 study, sponsored by University of Miami.
NCT04604275 is a Phase 2 study that was terminated before completion, run by University of Miami. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04604275, a Phase 2 study, was terminated before completion, sponsored by University of Miami.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
Short gut syndrome with intestinal failure patients may have decreased production of disaccharidases, like sucrase, an enzyme responsible for digesting sugar in foods. This can happen due to loss of bowel length from surgery or from loss of cellular function in the intestines due to use of parenteral nutrition intravenously. Therefore, patients with these conditions may not be able to digest sucrose (sugar) fully. Patients might experience abdominal distension/pain, vomiting and diarrhea when sugar is taken in orally or through the g-tube, which can limit patients' ability to increase oral or g-tube feeds in short gut syndrome patients with intestinal failure. In patients with short gut syndrome and intestinal failure, the administration of exogenous sucrase (enzyme) may improve sucrose (sugar) digestion and thus the ability to tolerate more oral or g-tube feeds.
Primary Outcome
Degree of carbohydrate malabsorption will be assessed by decrease in number of stools per day.
Interventions
- OTHER Placebo
- DRUG Sucrase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2022-01-31 |
| Est. Completion | 2024-09-01 |
| Phase | Phase 2 |
Why NCT04604275 stopped before completion
NCT04604275 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04604275 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04604275 about?
NCT04604275 is a clinical study titled "Functional Sucrase Deficiency in Short Bowel Syndrome Patients With Intestinal Failure". Short gut syndrome with intestinal failure patients may have decreased production of disaccharidases, like sucrase, an enzyme responsible for digesting sugar in foods. This can happen due to loss of bowel length from surgery or from loss of cellular function in the intestines due to use of parentera...
What is the current status of trial NCT04604275?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2022-01-31. Estimated completion is 2024-09-01.
What interventions are being tested in trial NCT04604275?
The interventions under investigation include: Placebo (OTHER), Sucrase (DRUG).
Who is sponsoring clinical trial NCT04604275?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04604275's enrollment target sits among peer trials
3 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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