New device could free kids with short bowel from IV nutrition
NCT ID NCT03530852
First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 4 times
Summary
This study tests a device called RELiZORB that pre-digests fat in tube feedings for children with short bowel syndrome who rely on IV nutrition. The goal is to see if it helps them absorb more nutrients and reduce their need for IV feeding. About 32 children aged 2 to 18 will use the device daily for 90 days.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2018
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female patients, ages 2 years to 18 years, inclusive. 2. 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). 3. Congenital or acquired gastrointestinal disease requiring surgical intervention that has occurred at least 3 months prior to screening. 4. 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 5. 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. 6. The patient has a Central Venous Catheter (CVC) at the time of study inclusion. 7. Screening direct bilirubin that is in the normal range for age and is not determined to be clinically significant by the investigator. 8. The patient has an existing feeding tube, receiving enteral nutrition via an enteral feeding pump at a rate\>10ml/hr but \<400 ml/hr, and is able to tolerate at least 10 ml/kg/day enteral nutrition with which the RELiZORB cartridge can be used. The patient can be on bolus or continuous feeds and can use up to 6 cartridges per day for feeding. 9. Stable enteral nutrition requirement with no change in formula composition or rate for at least 1 month prior to screening. 10. The parent or legal guardian of the patient is able to read, understand, and is willing to provide informed consent (and assent, if applicable). 11. The patient (if assent is applicable) or parent or legal guardian of the patient is able to understand the requirements of the study and is willing to bring the patient to all clinic visits and complete all study related procedures (as determined by the investigator). 12. A parent or legal guardian is willing to provide written authorization for the use and disclosure of protected health information. Exclusion criteria: 1. 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). 2. The patient has had a bowel lengthening procedure, including but not limited to, a STEP procedure. 3. Any serum triglyceride concentration \>400 mg/dL at screening. 4. Pancreatic insufficiency as defined as the use of pancreatic enzymes within 30 days prior to screening. 5. Evidence of untreated intestinal obstruction or active stenosis, as determined by the investigator. 6. Unstable absorption due to cystic fibrosis or known DNA abnormalities (i.e., familial adenomatous polyposis, Fanconi syndrome) as determined by the investigator. 7. History of microvillus inclusion disease, as determined by medical history. 8. Severe known dysmotility syndrome (i.e., pseudo-obstruction, gastroschisis-related motility disorders), as determined by the investigator. 9. Initiation of teduglutide or other GLP-2 analogues within 6 months of screening 10. Use of growth hormone, or supplemental glutamine within 3 months prior to screening. 11. Use of cisapride within 30 days prior to screening. 12. Active clinically significant pancreatic or biliary disease, as determined by the investigator. 13. Patients are receiving formulas that are not compatible with the RELiZORB cartridge (example, insoluble fiber-containing formulas) 14. Determined by the investigator to be unsuitable for participation for any reason.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Boston Children's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
Contact Email: •••••@•••••
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Children's Hospital Los Angeles
RECRUITINGLos Angeles, California, 90027, United States
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Other studies related to the condition(s) this trial covers.
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- Measuring hidden energy needs: a clue to better nutrition for gut failure patients
- Weekly shot could help people with short bowel syndrome absorb more fluids
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- Could a Plant-Based powder cut the need for IV nutrition?
- Growth hormone shows promise for weaning kids off IV nutrition