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

ConditionsShort Bowel Syndrome Malabsorption

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age2-18

SponsorBoston Children's Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Relizorb
Device
Tube feeds run across device to digest fats.

Treatment groups

32 Participants

are divided into 1 treatment group

Group A: Relizorb treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

90 days

Secondary outcomes

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.

Time frame

90 days

Sponsors and contacts

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Boston Children's Hospital

Lead sponsor

Alcresta Therapeutics, Inc.

Collaborator

Food and Drug Administration (FDA)