A 90 Day, Phase 3,Open Labeled Exploratory Study of RELiZORB (NCT03530852)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: Children's Hospital Los Angeles โ Los Angeles, California
Age range: 2 Years to 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (2 Sites)
- Children's Hospital Los Angeles โ Los Angeles, California
- Boston Children's Hospital โ Boston, Massachusetts
๐ Contact the Study Coordinator
Phone: (617) 355-1838
Email: mark.puder@childrens.harvard.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Short Bowel Syndrome
- Registry for Participants With Short Bowel Syndrome โ Lexington, Massachusetts
- Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS โ Washington D.C., District of Columbia
- Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial โ Washington D.C., District of Columbia
- Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome โ Cleveland, Ohio
- Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome. โ Los Angeles, California
- A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients With Short Bowel Syndrome โ Palo Alto, California
Explore by condition: All Short Bowel Syndrome clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.