A 90 Day, Phase 3,Open Labeled Exploratory Study of RELiZORB
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-18
SponsorBoston Children's Hospital
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
Other causes of chronic liver disease other than SBS (i.e., hepatitis C, cystic fibrosis, biliary atresia, alpha 1 anti-trypsin deficiency, and Alagille syndrome).
The patient has had a bowel lengthening procedure, including but not limited to, a STEP procedure.
Any serum triglyceride concentration >400 mg/dL at screening.
Pancreatic insufficiency as defined as the use of pancreatic enzymes within 30 days prior to screening.
Trial design
Treatments tested in this trial
- Relizorb
Treatment groups
32 Participants
are divided into 1 treatment groupSponsors and collaborators
Boston Children's Hospital
Lead sponsor
Alcresta Therapeutics, Inc.
Collaborator
Source ClinicalTrials.gov