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

NCT03530852 | Recruiting DMC FDA Device

• 1 other identifier: P00028297
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Short Bowel Syndrome; Malabsorption

Outcome Measures

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.

  90 days

Secondary Outcomes (1)

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

  90 days

Study Arms (1)

Relizorb treatment

EXPERIMENTAL

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

Device: Relizorb

Interventions

Relizorb DEVICE

Tube feeds run across device to digest fats.

Relizorb treatment

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Screening direct bilirubin that is in the normal range for age and is not determined to be clinically significant by the investigator.
• Subject has an existing feeding tube, is receiving enteral nutrition via a pump at a rate\>10ml/hr but \<120ml/hr, and is able to tolerate at least 10 ml/kg/day enteral nutrition.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Alcresta Therapeutics, Inc.: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 28471913 RESULT

• 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.

  PMID: 36857339 DERIVED

MeSH Terms

Conditions

Short Bowel Syndrome; Malabsorption Syndromes

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mark Puder, MD, PhD.

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Puder, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor Pediatric General Surgery

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: May 21, 2018
• Study Start: November 21, 2018
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)