What is RELiZORB studying for children with Short Bowel Syndrome?

RELiZORB is being studied to see if it can improve fat absorption from tube feeding in children with Short Bowel Syndrome who rely on intravenous nutrition. The study evaluates whether this device can reduce the need for intravenous nutrition by enhancing digestion and nutrient uptake. Boston Children's Hospital is leading this research to explore safer nutrition options for these children.

Who may be eligible for this Short Bowel Syndrome clinical trial?

Children aged 2 to 18 years diagnosed with Short Bowel Syndrome who depend on parenteral nutrition and have an existing feeding tube may be eligible. Participants should have stable nutrition needs and no recent bowel lengthening surgery or pancreatic enzyme use. 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. However, personal travel and related expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase Not Applicable

Age: 2Years - 18Years

All Genders

ID03530852

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

Led by Boston Children's Hospital · Updated on 2025-12-17

Participants Needed

Research Sites

65 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the safety, tolerability, and nutrient absorption of the RELiZORB enzyme cartridge in children aged 2 to 18 years with Short Bowel Syndrome SBS who depend on parenteral nutrition PN. SBS causes inadequate intestinal absorption due to significant loss of small bowel, requiring intravenous nutrition to maintain hydration and nutrition but leading to complications such as liver failure. The study explores whether predigesting fats with RELiZORB can improve absorption and reduce reliance on PN. The RELiZORB device is an enzyme cartridge connected to enteral feeding tubes that mimics pancreatic lipase to digest fats before they enter the gut, aiming to improve fat absorption without the need for bile acid emulsification. Participants will receive tube feeding through the device daily for 90 days. The study monitors changes in PN calories over time, along with growth, fecal fat, plasma fatty acids, and nutrition intake. Participants will be assessed at multiple time points during the 90-day treatment to evaluate PN calorie reduction and nutritional status. Safety and tolerability will be monitored by recording adverse events. The study involves regular clinical visits, laboratory tests, and nutrition assessments to measure the effectiveness of RELiZORB in improving enteral nutrition absorption and supporting growth while reducing PN dependence.

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 inclusive
Diagnosed with Short Bowel Syndrome and dependent on parenteral nutrition for more than 60 days after intestinal resection or with bowel length less than 25% of expected
Gastrointestinal disease requiring surgery at least 3 months before screening
Receiving parenteral lipid and at least 30% of daily calories and fluids from parenteral nutrition for at least 6 months before screening
Stable parenteral nutrition requirements with less than 5% reduction in calories for at least 1 month before screening or as determined by investigator
Normal screening direct bilirubin levels for age without clinical significance
Existing feeding tube with enteral nutrition via pump at rates over 10 ml/hr but under 120 ml/hr, and able to tolerate at least 10 ml/kg/day enteral nutrition
Stable enteral nutrition without changes in formula or rate for at least 1 month before screening
Parent or legal guardian able to provide informed consent and willing to bring patient to clinic visits
Patient or guardian able to understand study requirements and complete procedures as determined by investigator
Parent or guardian willing to authorize use and disclosure 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 antitrypsin deficiency, or Alagille syndrome
Previous bowel lengthening surgery including STEP procedure
Serum triglyceride levels over 400 mg/dL at screening
Pancreatic insufficiency or use of pancreatic enzymes within 30 days before screening
Untreated intestinal obstruction or active stenosis
Unstable absorption due to cystic fibrosis or known DNA abnormalities like familial adenomatous polyposis or Fanconi syndrome
History of microvillus inclusion disease
Severe motility disorders such as pseudo-obstruction or gastroschisis-related motility problems
Use of teduglutide or other GLP-2 analogues within 6 months before screening
Use of growth hormone or supplemental glutamine within 3 months before screening
Use of cisapride within 30 days before screening
Active significant pancreatic or biliary disease
Receiving formulas incompatible with RELiZORB, such as those containing insoluble fiber
Investigator judgment of unsuitability for study participation for any reason

Research Team

Mark Puder, MD, PhD

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