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
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
• Male or female patients, ages 2 years to 18 years, inclusive.
• Diagnosed with SBS, as determined by medical history and PN dependence (i.e. need for PN for >60 days after intestinal resection or a bowel length <25% of expected).
• Congenital or acquired gastrointestinal disease requiring surgical intervention that has occurred at least 3 months prior to screening.
• Patient is on parenteral lipid and at least 30% of daily caloric and fluid intake has been provided by PN for a least 6 months prior to screening
• Stable PN nutrition requirement, determined by less than 5% reduction in PN nutrition calories for at least 1 month prior to screening, or at the discretion of the investigator.
• Screening direct bilirubin that is in the normal range for age and is not determined to be clinically significant by the investigator.
• Subject has an existing feeding tube, is receiving enteral nutrition via a pump at a rate>10ml/hr but <120ml/hr, and is able to tolerate at least 10 ml/kg/day enteral nutrition.
• Stable enteral nutrition requirement with no change in formula composition or rate for at least 1 month prior to screening.
• 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.