RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2018-11-21

Study Completion:2028-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03530852

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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. Screening direct bilirubin that is in the normal range for age and is not determined to be clinically significant by the investigator. 7. 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. 8. Stable enteral nutrition requirement with no change in formula composition or rate for at least 1 month prior to screening. 9. The parent or legal guardian of the patient is able to read, understand, and is willing to provide informed consent (and assent, if applicable). 10. 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).	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.

Inclusion Criteria

Exclusion 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. Screening direct bilirubin that is in the normal range for age and is not determined to be clinically significant by the investigator.
7. 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.
8. Stable enteral nutrition requirement with no change in formula composition or rate for at least 1 month prior to screening.
9. The parent or legal guardian of the patient is able to read, understand, and is willing to provide informed consent (and assent, if applicable).
10. 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).

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.

Contacts and Locations

Study Contact

Mark Puder, MD, PhD

CONTACT

617-355-1838

mark.puder@childrens.harvard.edu

Principal Investigator

Mark Puder, MD, PhD.

PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Study Locations (Sites)

Boston Children's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

Mark Puder, MD, PhD., PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-11-21

Study Completion Date2028-09-30

Study Record Updates

Study Start Date2018-11-21

Study Completion Date2028-09-30

Terms related to this study

Additional Relevant MeSH Terms

Short Bowel Syndrome
Malabsorption