RecruitingNot ApplicableNCT03530852

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

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

Sponsor

Boston Children's Hospital

Enrollment

32 participants

Start Date

Nov 21, 2018

Study Type

INTERVENTIONAL

Conditions

Malabsorption Short Bowel Syndrome

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

Eligibility

Min Age: 2 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Relizorb for people with malabsorption and short bowel syndrome. The study is currently recruiting participants at 1 location. People eligible for this study include aged 2 Years to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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