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

NCT05635747 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2025-12-30

No results posted yet for this study

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

Conditions

  • Short Bowel Syndrome
  • Malabsorption

Interventions

DEVICE

Relizorb Enzyme Cartridge

Tube feeds run across device to digest fats.

Sponsors & Collaborators

Principal Investigators

  • Mark Puder, MD, PhD · Boston Children's Hospital

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-29
Primary Completion
2026-09-29
Completion
2027-09-29
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05635747 on ClinicalTrials.gov