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

Conditions

• Malabsorption
• Short Bowel Syndrome

Eligibility Criteria

Sex

ALL

Age

2 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Relizorb Enzyme Cartridge — DEVICE
  Tube feeds run across device to digest fats.

Study Details

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 Dates

Start date

Sep 29, 2022

Status verified

Dec 2025

Primary completion

Sep 29, 2026

Completion

Sep 29, 2027

Study Design

Enrollment

32 participants (estimated)

Arms

• Arm: Patients who have completed the Relizorb Trial and consented into the 90 day extension trial
  Patients aged 2-18 who have completed the 90 day open label phase 3 Relizorb trial who consent to the 90 day observational Relizorb extension trial

Primary Outcome Measure

To evaluate the effect of the RELiZORB enzyme cartridge when used with enteral nutrition daily for an additional 90 days [ Time Frame: 90 days ]

Locations (1)

Find similar trials in Boston, MA

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