NCT03530852 A 90 Day, Phase 3,Open Labeled Exploratory Study of RELiZORB
| NCT ID | NCT03530852 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Children's Hospital |
| Condition | Short Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2018-11-21 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2018-11-21 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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. 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). 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.
Contact & Investigator
Mark Puder, MD, PhD.
PRINCIPAL INVESTIGATOR
Boston Children's Hospital
Frequently Asked Questions
Who can join the NCT03530852 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 18 Years, studying Short Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03530852 currently recruiting?
Yes, NCT03530852 is actively recruiting participants. Contact the research team at mark.puder@childrens.harvard.edu for enrollment information.
Where is the NCT03530852 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT03530852 clinical trial?
NCT03530852 is sponsored by Boston Children's Hospital. The principal investigator is Mark Puder, MD, PhD. at Boston Children's Hospital. The trial plans to enroll 32 participants.