ClinicalTrials.gg
RecruitingNCT03530852Updated Aug 3, 2026

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

An interventional study of Relizorb in Short Bowel Syndrome and Malabsorption, sponsored by Boston Children's Hospital. Recruiting at 2 sites in United States. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2018; still recruiting 7 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
2 Years to 18 Years
Sex
All
01

Study 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

Read the detailed description

Project Summary/Abstract

Short bowel syndrome (SBS) is often due to the loss of large amounts of small intestine that compromises digestive absorption. The treatments include (1) a high-calorie diet that includes vitamins, minerals, carbohydrates, proteins and fats; (2) injections of vitamins and minerals; (3) administration of drugs to slow the normal movement of the intestine or to increase the surface area of the intestinal lining; and (4) feeding through the vein (i.e., parenteral nutrition or PN). Many patients cannot wean from PN due to reduced intestinal length or function. Patients on long-term PN frequently experience serious metabolic complications, sepsis, hepatic biliary disorders including cholestasis, and fibrosis and can progress to liver failure. Full intestinal feeding (enteral nutrition) without PN is the optimal way to prevent the above complications.

Enterally administered long chain triglycerides in patients with SBS, especially those with hepatic dysfunction, are not well tolerated due to bile acid malabsorption, which leads to decreased micelle formation and fat digestion. The dietary fat is unable to be emulsified by the bile acids and acted on by lipases before exiting the patient as stool. Switching to other forms of fat such as medium-chain triglycerides (MCTs) that do not require micelles for absorption may be better tolerated in patients with bile acid or pancreatic insufficiency but are not optimal as they increase the osmotic load in the intestine. This may increase the chance of stool dumping; moreover, MCTs do not contain essential fatty acids (FAs). The ability to provide the essential FAs such as those present in enteral formulas in a form that does not require the formation of micelles for absorption, would allow patients with SBS and those who are no longer PN dependent to receive adequate nutrition and continue to maintain the same growth trajectory as when they received the majority of their nutrition parenterally.

RELiZORB is a digestive enzyme cartridge connected in-line with enteral feed tubing sets designed to mimic the function of pancreatic lipase. It is hypothesized that by using an external lipase device (RELiZORB) enteral nutrition will be better absorbed, and PN dependence reduced as enteral autonomy is increased. This product uniquely eliminates the need for intestinal emulsification and lipase activity and eliminates the risk of drugs, including lipases, allowing absorption at the time the diet enters the gut. The device has been shown to digest >90% of fat in most enteral formulas.

This is a phase 3, open label single center clinical trial to determine the safety, tolerability, and bioavailability of the RELiZORB enzyme cartridge with enteral nutrition when used daily for 90 days in pediatric subjects with SBS, aged 2 years - 18 years, who are PN dependent. The change in PN calories from baseline, assessed at Day 7, 14, 28, 60, and 90, will be assessed by area under the curve and presented with a 95% confidence interval. The number (percent) of treatment-emergent adverse events, grade 2 or above, will be tabulated. Changes in growth, fecal fat, plasma FAs, PN volume, and enteral/oral nutrition will be described.

02

Conditions studied

  • Short Bowel Syndrome
  • Malabsorption
03

In context

Short Bowel Syndrome

159 studies on the registry are indexed under Short Bowel Syndrome; 24 are open to participants now.

This study's planned enrollment of 32 is above the median of 21 across 108 interventional studies indexed under Short Bowel Syndrome.

Browse Short Bowel Syndrome studies →

Lead sponsor

Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 that is in the normal range for age and is not determined to be 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 (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

Exclusion criteria:

  1. Other causes of chronic liver disease other than SBS (i.e., , 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 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    Relizorb treatment

    Patients will have tube feeds placed through chamber and evaluate wean from parenteral nutrition

    Device: Relizorb

Interventions

  • DeviceRelizorb

    Tube feeds run across device to digest fats.

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 90 days

Secondary outcomes

  1. Effectiveness of the RELiZORB enzyme cartridge on the absorption of enteral nutrition based on body weight change

    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 body weight 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.

    Time frame: 90 days

07

Study locations

2 of 2 sites recruiting
08

References and documents

Publications

  • Freedman S, Orenstein D, Black P, Brown P, McCoy K, Stevens J, Grujic D, Clayton R. Increased Fat Absorption From Enteral Formula Through an In-line Digestive Cartridge in Patients With Cystic Fibrosis. J Pediatr Gastroenterol Nutr. 2017 Jul;65(1):97-101. doi: 10.1097/MPG.0000000000001617. PubMed 28471913 ↗
  • Tsikis ST, Fligor SC, Mitchell PD, Hirsch TI, Carbeau S, First E, Loring G, Rudie C, Freedman SD, Martin CR, Gura KM, Puder M. Fat digestion using RELiZORB in children with short bowel syndrome who are dependent on parenteral nutrition: Protocol for a 90-day, phase 3, open labeled study. PLoS One. 2023 Mar 1;18(3):e0282248. doi: 10.1371/journal.pone.0282248. eCollection 2023. PubMed 36857339 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2018 (actual). Primary completion is estimated for Jun 2027, 103 months after the start.

Of 24 interventional studies with no phase under Short Bowel Syndrome, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 59. This study's planned 103 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 13, 2018
First posted
May 21, 2018
StartActual
Nov 21, 2018
Primary completionEst.
Jun 30, 2027
CompletionEst.
Sep 30, 2028
Last update
Aug 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03530852
Collaborators
Alcresta Therapeutics, Inc., Food and Drug Administration (FDA)
Responsible party
Mark Puder (MD, PhD, Professor Pediatric General Surgery, Boston Children's Hospital) — Principal investigator
First posted
May 21, 2018
Start date
Nov 21, 2018
Primary completion
Jun 30, 2027 (estimated)
Completion
Sep 30, 2028 (estimated)
Last update
Aug 3, 2026

Study contacts

Mark Puder, MD, PhD
Contact
mark.puder@childrens.harvard.edu
617-355-1838
Mark Puder, MD, PhD.
principal investigator · Boston Children's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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