Increased Fat Absorption From Enteral Formula Through an In-line Digestive Cartridge in Patients With Cystic Fibrosis.
Steven Freedman, David Orenstein, Philip Black...
https://pubmed.ncbi.nlm.nih.gov/28471913Actively 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
32
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
Sponsors
B
Boston Children's Hospital
Lead Sponsor
A
Alcresta Therapeutics, Inc.
Collaborating Sponsor
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 90 days
Participants use the RELiZORB enzyme cartridge daily with their enteral nutrition to aid fat digestion and support weaning from parenteral nutrition.
Visits on Day 7, 14, 28, 60, and 90 for assessments
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
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Research Team
M
Mark Puder, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Fat digestion using RELiZORB in children with short bowel syndrome who are dependent on parenteral nutrition: Protocol for a 90-day, phase 3, open labeled study.
Savas T Tsikis, Scott C Fligor, Paul D Mitchell...
https://pubmed.ncbi.nlm.nih.gov/36857339