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RECRUITING
NCT03530852
NA

A 90 Day, Phase 3,Open Labeled Exploratory Study of RELiZORB

Sponsor: Boston Children's Hospital

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

2 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2018-11-21

Completion Date

2028-09-30

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

DEVICE

Relizorb

Tube feeds run across device to digest fats.

Locations (1)

Boston Children's Hospital

Boston, Massachusetts, United States