What is RELiZORB studying for children with short bowel syndrome?

RELiZORB is being studied to see if it can improve fat absorption in children with short bowel syndrome who depend on intravenous nutrition. The device is designed to digest fats in tube feeding, potentially reducing the need for IV nutrition. Boston Children's Hospital is leading this research to help improve nutrition management in these children.

Who may be eligible for this short bowel syndrome clinical trial?

Children aged 2 to 18 years with a diagnosis of short bowel syndrome who require parenteral nutrition and have a stable nutrition requirement may be eligible. Participants must have a feeding tube and a central venous catheter. Please review eligibility criteria for more details.

Is there any cost to participate in this short bowel syndrome clinical trial?

Study-related care, including the device and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 2Years - 18Years

All Genders

ID03530852

Study of RELiZORB Device to Improve Fat Absorption and Reduce IV Nutrition in Children With Short Bowel Syndrome Over 90 Days

Led by Boston Children's Hospital · Updated on 2026-08-03

Participants Needed

Research Sites

65 weeks

Total Duration

AI-Summary

What this Trial Is About

Children with short bowel syndrome SBS have reduced intestinal length or function, causing poor absorption of nutrients and requiring intravenous nutrition parenteral nutrition, PN to sustain hydration and nutrition. Long-term PN use can lead to serious complications including liver failure. This study evaluates the RELiZORB enzyme cartridge, a device designed to improve fat digestion and absorption by predigesting fats in enteral feeding tubes, potentially reducing the need for PN in children aged 2 to 18 years who are PN dependent. Participants will use the RELiZORB device connected inline with their enteral feeding tubes daily for 90 days. The device mimics pancreatic lipase to digest fats before they enter the intestine, bypassing the need for bile acid emulsification. Tube feeds run across the device to enhance fat absorption. This open-label, single-group trial monitors changes in PN calories, growth, fecal fat, plasma fatty acids, and nutrition intake over the study period. During the study, participants will have assessments at multiple timepoints including days 7, 14, 28, 60, and 90. Researchers will measure effectiveness by changes in PN calorie requirements and weight, monitor safety by tracking adverse events, and evaluate tolerability. The study also involves tracking growth, stool fat content, blood fatty acid levels, and nutrition intake. The total participation duration is 90 days, with regular clinic visits for monitoring and data collection.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 2Years - 18Years

All Genders

Eligibility Criteria

You may qualify if you...

Male or female patients aged 2 to 18 years.
Diagnosed with short bowel syndrome and dependent on parenteral nutrition for more than 60 days after intestinal surgery or having less than 25% of expected bowel length.
Gastrointestinal surgery performed at least 3 months prior to screening.
Receiving parenteral lipid and at least 30% of daily calories and fluids from parenteral nutrition for at least 6 months.
Stable parenteral nutrition requirement with less than 5% reduction in calories for at least 1 month prior to screening.
Central venous catheter in place at study inclusion.
Normal screening direct bilirubin levels for age.
Existing feeding tube with enteral nutrition at a rate greater than 10 ml/hr but less than 400 ml/hr, tolerating at least 10 ml/kg/day.
Stable enteral nutrition with no formula or rate changes for at least 1 month prior to screening.
Parent or legal guardian able to provide informed consent and understand study requirements.
Willingness to attend all clinic visits and complete study procedures.
Parent or legal guardian authorization for use of protected health information.

You will not qualify if you...

Chronic liver diseases other than short bowel syndrome, such as hepatitis C, cystic fibrosis, biliary atresia, alpha 1 anti-trypsin deficiency, or Alagille syndrome.
History of bowel lengthening procedures like STEP.
Serum triglyceride concentration over 400 mg/dL at screening.
Use of pancreatic enzymes within 30 days before screening.
Untreated intestinal obstruction or active stenosis.
Unstable absorption due to cystic fibrosis or genetic abnormalities.
History of microvillus inclusion disease.
Severe motility disorders such as pseudo-obstruction or gastroschisis-related dysmotility.
Started teduglutide or other GLP-2 analogues within 6 months prior to screening.
Use of growth hormone or glutamine supplements within 3 months before screening.
Use of cisapride within 30 days prior to screening.
Active significant pancreatic or biliary disease.
Use of formulas incompatible with the RELiZORB device (e.g., containing insoluble fiber).
Investigator's determination of unsuitability for participation.

Research Team

Mark Puder, MD, PhD

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Study of RELiZORB Device to Improve Fat Absorption and Reduce IV Nutrition in Children With Short Bowel Syndrome Over 90 Days

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria