RELiZORB for Short Bowel Syndrome in Children
This study is looking at how well a device called RELiZORB helps children aged 2 to 18 years old with Short Bowel Syndrome (SBS) absorb fats from their tube feedings. SBS means your child's small intestine can't absorb enough nutrients, often requiring intravenous nutrition (feeding through a vein). While IV nutrition helps, it can lead to serious problems like liver damage. This study aims to see if RELiZORB, which predigests fats in tube feeds, can improve nutrient absorption and potentially reduce or eliminate the need for IV nutrition. The main goal is to measure how much IV nutrition your child needs after 90 days of using RELiZORB. The current status of this study is unclear.
- Study design
- This is an open-label study, meaning both you and the study team will know your child is receiving RELiZORB. It plans to enroll 32 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at 90 days, indicating a follow-up period of at least this duration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A 90 Day, Phase 3,Open Labeled Exploratory Study of RELiZORB
At a glance
Conditions
NCT03530852
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Boston Children's Hospital
Boston, Massachusettsstudy coordinator listed
Recruiting
Children's Hospital Los Angeles
Los Angeles, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Mark Puder, MD, PhD. · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Effectiveness of the RELiZORB enzyme cartridge on the absorption of enteral nutrition based on PN calories90 days
To determine the effectiveness of the RELiZORB enzyme cartridge on the absorption of enteral nutrition when used daily for a total 90 days of treatment, in pediatric subjects with SBS who are PN dependent, aged 2 years - 18 years, by measuring the change in PN calories from baseline, assessed at days 7, 14, 28, 60, and day 90. Each subject will be on the study for a total of 90 days.