A 90 Day Observational Study as an Extension to the Phase 3,Open Labeled Exploratory Study of REL… (NCT05635747) | Clinical Trial Compass
By InvitationNot Applicable
A 90 Day Observational Study as an Extension to the Phase 3,Open Labeled Exploratory Study of RELiZORB
United States32 participantsStarted 2022-09-29
Plain-language summary
Children with inadequate intestinal absorption due to loss of large amounts of small bowel require intravenous nutrition (feeding through the vein) to sustain hydration and nutrition to avoid starvation and dehydration; however, intravenous (IV) nutrition can lead to complications including liver failure. Tube feeding directly to the small intestine avoids the complications of IV nutrition, but fats are not fully digestible due to inadequate bowel function. We propose to predigest the fat using a small cartridge attached to the feeding tube to allow for rapid absorption with the possibility of reducing or eliminating the need for intravenous nutrition. Goal of the observational study is to determine safety and tolerability of Relizorb Enzyme Cartridge for an additional 90 days after the original trial
Who can participate
Age range2 Years – 18 Years
SexALL
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
✓. Patient is currently enrolled in the ongoing RELiZORB study titled "A 90 day, Phase 3, Open Labeled Exploratory Study of RELiZORB to Evaluate Safety, Tolerability, and Nutrient Absorption in Children with Short Bowel Syndrome who are Dependent on Parenteral Nutrition"
✓. The parent or legal guardian of the patient is able to read, understand, and is willing to provide informed consent (and assent, if applicable).
✓. The patient (if assent is applicable) or parent or legal guardian of the patient is able to understand the requirements of the study and is willing to bring the patient to all clinic visits and complete all study-related procedures (as determined by the investigator).
✓. A parent or legal guardian is willing to provide written authorization for the use and disclosure of protected health information.
Exclusion criteria
✕. Active clinically-significant pancreatic or biliary disease, as determined by the investigator.
✕. Change in patient formula such that the new formula is not compatible with the RELiZORB cartridge (example, insoluble fiber-containing formulas)
✕
What they're measuring
1
To evaluate the effect of the RELiZORB enzyme cartridge when used with enteral nutrition daily for an additional 90 days