drugset / Trial / NCT04604275

Functional Sucrase Deficiency in Short Bowel Syndrome Patients With Intestinal Failure

NCT04604275 ↗

Phase 2 Terminated 3 enrolled University of Miami QOL Medical, LLC · collab
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2022-01-31
Primary completion
2024-09-01
Completion
2024-09-01

Outcome

Outcome not reported

Stopped (Enrollment): “Inability to recruit further patients for study”

Drugs

EvaluationDrugModalityDoseRoute
Subject Sucrase Protein / enzyme biologic 1 ml Oral
Subject Sucrase Protein / enzyme biologic 2 ml Oral

Indications