Actively Recruiting
A 90 Day, Phase 3,Open Labeled Exploratory Study of RELiZORB
Led by Boston Children's Hospital · Updated on 2025-12-17
32
Participants Needed
1
Research Sites
514 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
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
CONDITIONS
Official Title
A 90 Day, Phase 3,Open Labeled Exploratory Study of RELiZORB
Who Can Participate
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
- Congenital or acquired gastrointestinal disease requiring surgical intervention at least 3 months before screening
- Receiving parenteral lipid with at least 30% of daily calories and fluids from parenteral nutrition for at least 6 months prior to screening
- Stable parenteral nutrition with less than 5% reduction in calories for at least 1 month before screening or as determined by investigator
- Screening direct bilirubin within normal range for age and not clinically significant
- Has an existing feeding tube with enteral nutrition via pump at a rate greater than 10 ml/hr but less than 120 ml/hr, able to tolerate at least 10 ml/kg/day enteral nutrition
- Stable enteral nutrition with no changes in formula composition or rate for at least 1 month prior to screening
- Parent or legal guardian able to read, understand, and provide informed consent (and assent if applicable)
- Patient or guardian able to understand study requirements and comply with clinic visits and procedures
- Parent or legal guardian provides authorization for use and disclosure of protected health information
You will not qualify if you...
- Other chronic liver diseases besides short bowel syndrome (e.g., hepatitis C, cystic fibrosis, biliary atresia, alpha 1 anti-trypsin deficiency, Alagille syndrome)
- History of bowel lengthening procedures including STEP procedure
- Serum triglyceride concentration over 400 mg/dL at screening
- Pancreatic insufficiency requiring pancreatic enzymes within 30 days before screening
- Untreated intestinal obstruction or active stenosis
- Unstable absorption due to cystic fibrosis or genetic abnormalities as determined by investigator
- History of microvillus inclusion disease
- Severe dysmotility syndromes such as pseudo-obstruction or gastroschisis-related motility disorders
- Initiation 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 clinically significant pancreatic or biliary disease
- Receiving formulas incompatible with RELiZORB cartridge (e.g., insoluble fiber-containing formulas)
- Investigator determines patient unsuitable for participation for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
M
Mark Puder, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here