Exploring a new way to help children with short bowel syndrome absorb nutrients

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

This study is testing a new device that helps children with short bowel syndrome absorb fats better from their feeding tube to see if it can reduce their need for intravenous nutrition.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 2 Years to 18 Years
• Sex: All
• Sponsor: Boston Children's Hospital (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT03530852 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of RELiZORB, a device designed to predigest fats for children suffering from short bowel syndrome (SBS) who are dependent on intravenous nutrition. The study aims to improve nutrient absorption by attaching the RELiZORB cartridge to the feeding tube, potentially reducing the need for parenteral nutrition and its associated complications. Participants will include children aged 2 to 18 years who have been on parenteral nutrition for an extended period due to their condition. The trial will assess the effectiveness of this approach in enhancing enteral nutrition and overall health outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 2 to 18 years diagnosed with short bowel syndrome who have been dependent on parenteral nutrition for at least 6 months.

Not a fit: Patients who do not have short bowel syndrome or those who are not dependent on parenteral nutrition may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve nutrient absorption in children with SBS, reducing reliance on intravenous nutrition and its complications.

How similar studies have performed: While there have been studies exploring enteral nutrition in SBS, the specific use of RELiZORB for fat predigestion represents a novel approach that has not been extensively tested.

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.

Where this trial is running

Boston, Massachusetts

• Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Mark Puder, MD, PhD. — Boston Children's Hospital
• Study coordinator: Mark Puder, MD, PhD

Conditions Short Bowel Syndrome; Malabsorption