Short Bowel SyndromeNCT03530852
A 90 Day, Phase 3,Open Labeled Exploratory Study of RELiZORB
A study testing Relizorb in people with Short Bowel Syndrome and Malabsorption, run by Boston Children's Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Short Bowel Syndrome, Malabsorption
- What is being tested?
- Relizorb
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Nov 2018to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
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- Screening direct bilirubin that is in the normal range for age and is not determined to be clinically significant by the investigator.
- 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.
- Stable enteral nutrition requirement with no change in formula composition or rate for at least 1 month prior to screening.
- The parent or legal guardian of the patient is able to read, understand, and is willing to provide informed consent (and assent, if applicable).
- 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).
- A parent or legal guardian is willing to provide written authorization for the use and disclosure of protected health information.
Who cannot join
- 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).
- The patient has had a bowel lengthening procedure, including but not limited to, a STEP procedure.
- Any serum triglyceride concentration >400 mg/dL at screening.
- Pancreatic insufficiency as defined as the use of pancreatic enzymes within 30 days prior to screening.
- Evidence of untreated intestinal obstruction or active stenosis, as determined by the investigator.
- Unstable absorption due to cystic fibrosis or known DNA abnormalities (i.e., familial adenomatous polyposis, Fanconi syndrome) as determined by the investigator.
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- History of microvillus inclusion disease, as determined by medical history.
- Severe known dysmotility syndrome (i.e., pseudo-obstruction, gastroschisis-related motility disorders), as determined by the investigator.
- Initiation of teduglutide or other GLP-2 analogues within 6 months of screening
- Use of growth hormone, or supplemental glutamine within 3 months prior to screening.
- Use of cisapride within 30 days prior to screening.
- Active clinically significant pancreatic or biliary disease, as determined by the investigator.
- Patients are receiving formulas that are not compatible with the RELiZORB cartridge (example, insoluble fiber-containing formulas)
- Determined by the investigator to be unsuitable for participation for any reason.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Mark Puder, MD, PhD, 617-355-1838, relizorbstudy@childrens.harvard.edu
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Jillene Wong, 323-361-3403, jiwong@chla.usc.edu
Atu Agawu, MD MPH MSCE
About this study
Official title: 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
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.
- Conditions
- Short Bowel Syndrome, Malabsorption
- Being tested
- Relizorb
- Medical subject headings
- Short Bowel Syndrome, Malabsorption Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RelizorbDevice
Tube feeds run across device to digest fats.
| Study group | Role | What they receive |
|---|---|---|
| Relizorb treatment | Experimental | Patients will have tube feeds placed through chamber and evaluate wean from parenteral nutrition Receives: Device: Relizorb |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start21 Nov 2018
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Alcresta Therapeutics, Inc., Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, Mark Puder, Boston Children's Hospital
- Investigators
- Mark Puder, MD, PhD., Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530852
- Sponsor's protocol ID
- P00028297
- Other IDs
- R01FD006349
- Status last verified
- Jul 2026
- First submitted
- 13 Apr 2018
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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 28471913Tsikis 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03530852
- Acronym / sponsor ID
- P00028297
- Conditions
- Short Bowel Syndrome, Malabsorption
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Alcresta Therapeutics, Inc., Food and Drug Administration (FDA)
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relizorb treatment | Experimental | Device: RelizorbPatients will have tube feeds placed through chamber and evaluate wean from parenteral nutrition |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
- The patient has had a bowel lengthening procedure, including but not limited to, a STEP procedure.
- Any serum triglyceride concentration >400 mg/dL at screening.
- Pancreatic insufficiency as defined as the use of pancreatic enzymes within 30 days prior to screening.
- Evidence of untreated intestinal obstruction or active stenosis, as determined by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RelizorbTube feeds run across device to digest fats. | Device | Relizorb treatment |
Primary outcome
Effectiveness of the RELiZORB enzyme cartridge on the absorption of enteral nutrition based on PN calories
Time frame: 90 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.
1 secondary outcome
Effectiveness of the RELiZORB enzyme cartridge on the absorption of enteral nutrition based on body weight change
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Results publication: PubMed 28471913Freedman 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.
- Derived from this study: PubMed 36857339Tsikis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Puder, MD, PhD. principal investigator
Boston Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relizorb in people with Short Bowel Syndrome and Malabsorption, run by Boston Children's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Puder, MD, PhD (617-355-1838, mark.puder@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the RELiZORB enzyme cartridge on the absorption of enteral nutrition based on PN calories (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03530852, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.