RecruitingNot Applicable

A 90 Day, Phase 3,Open Labeled Exploratory Study of RELiZORB

United States32 participantsStarted 2018-11-21

Plain-language summary

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 participate

Age range

2 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. Stable PN nutrition requirement, determined by less than 5% reduction in PN nutrition calories for at least 1 month prior to screening, or at the discretion of the investigator.
. The patient has a Central Venous Catheter (CVC) at the time of study inclusion.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effectiveness of the RELiZORB enzyme cartridge on the absorption of enteral nutrition based on PN calories

Timeframe: 90 days

Trial details

NCT IDNCT03530852

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Mark Puder, MD, PhD

617-355-1838 mark.puder@childrens.harvard.edu

View on ClinicalTrials.gov More Short Bowel Syndrome trials

Plain-language summary

Who can participate

Age range

2 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. Stable PN nutrition requirement, determined by less than 5% reduction in PN nutrition calories for at least 1 month prior to screening, or at the discretion of the investigator.
. The patient has a Central Venous Catheter (CVC) at the time of study inclusion.

A 90 Day, Phase 3,Open Labeled Exploratory Study of RELiZORB

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

A 90 Day, Phase 3,Open Labeled Exploratory Study of RELiZORB

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria