A 90 Day Observational Study as an Extension to the Phase 3,Open Labeled Exploratory Study of RELiZORB

Enrolling by invitation

Conditions studied: Short Bowel Syndrome, Malabsorption

In brief

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

Key facts

Study ID

NCT05635747

Run by

Boston Children's Hospital

People needed

32

Starts

2022-09-29

Expected to finish

2027-09-29

Last updated by the study team

2026-07-06

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)
• Determined by the investigator to be unsuitable for participation for any reason.

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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