Functional Sucrase Deficiency in Short Bowel Syndrome Patients With Intestinal Failure (NCT04604275) | Clinical Trial Compass
TerminatedPhase 2
Functional Sucrase Deficiency in Short Bowel Syndrome Patients With Intestinal Failure
Stopped: Inability to recruit further patients for study
United States3 participantsStarted 2022-01-31
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Carbohydrate Malabsorption
Timeframe: baseline, 9 weeks
2
Change in Carbohydrate Malabsorption as Measured by Patient Symptom Survey
Timeframe: baseline, 9 weeks
3
Change in Carbohydrate Malabsorption as Measured by Growth Velocity
Timeframe: baseline, 9 weeks
4
Change in Carbohydrate Malabsorption as Measured by Enteral Nutrition Tolerance