32 Participants Needed

RELiZORB for Malabsorption Syndrome

MP
Overseen ByMark Puder, MD, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have used pancreatic enzymes, cisapride, or certain other medications within 30 days before screening.

What data supports the effectiveness of the treatment RELiZORB for Malabsorption Syndrome?

RELiZORB, an in-line digestive cartridge, has been shown to effectively break down over 90% of fats in enteral nutrition formulas, making them easier to absorb. This has been demonstrated in studies involving patients with conditions like short bowel syndrome and exocrine pancreatic insufficiency, where improved fat and vitamin absorption was observed.12345

Is RELiZORB safe for use in humans?

RELiZORB has been evaluated for safety in a clinical trial for children with short bowel syndrome, and it is designed to help with fat digestion in patients receiving enteral nutrition. The treatment is generally considered safe, with studies showing it effectively breaks down fats in enteral nutrition without significant safety concerns.12356

How is the treatment RELiZORB unique for malabsorption syndrome?

RELiZORB is unique because it is an immobilized lipase cartridge that helps break down fats in the digestive system, which is different from other treatments that may not directly aid in fat digestion. This makes it particularly useful for people with malabsorption syndrome who struggle to absorb fats from their diet.7891011

What is the purpose of 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

Research Team

MP

Mark Puder, MD, PhD

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

This trial is for children aged 2-18 with Short Bowel Syndrome (SBS) who rely on intravenous nutrition but can tolerate some tube feeding. They should have a stable nutritional regimen, an existing feeding tube, and not have had any significant changes in their enteral nutrition or parenteral nutrition requirements recently. Kids with certain conditions like liver disease unrelated to SBS or recent use of specific medications are excluded.

Inclusion Criteria

I have short bowel syndrome and need parenteral nutrition or have a significantly shorter bowel.
My nutritional needs via IV have been stable for the last month.
I or my guardian understand the study's needs and can attend all visits.
See 11 more

Exclusion Criteria

I do not have an untreated blockage or narrowing in my intestines.
I do not have severe stomach or bowel movement disorders.
Your blood test shows high levels of triglycerides, over 400 mg/dL.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the RELiZORB enzyme cartridge with enteral nutrition daily for 90 days

90 days
Visits at days 7, 14, 28, 60, and 90

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • RELiZORB
Trial Overview The study tests RELiZORB, a cartridge that predigests fats in the feeding tube formula, potentially improving nutrient absorption and reducing the need for IV nutrition. The goal is to see if this device helps kids absorb more nutrients directly through their intestines over a period of 90 days.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Relizorb treatmentExperimental Treatment1 Intervention
Patients will have tube feeds placed through chamber and evaluate wean from parenteral nutrition

RELiZORB is already approved in United States for the following indications:

🇺🇸
Approved in United States as RELiZORB for:
  • Fat malabsorption in pediatric patients (ages 2 and above) and adult patients receiving enteral nutrition

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

Alcresta Therapeutics, Inc.

Industry Sponsor

Trials
6
Recruited
240+

Findings from Research

The study is evaluating the safety and efficacy of the RELiZORB enzyme cartridge in children aged 2-18 with short bowel syndrome (SBS) who are dependent on parenteral nutrition (PN), aiming to reduce PN dependence and improve fat absorption over a 90-day period.
Preclinical studies have shown that the RELiZORB cartridge can significantly enhance fat and fat-soluble vitamin absorption, which could help prevent complications associated with long-term PN use in SBS patients.
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.Tsikis, ST., Fligor, SC., Mitchell, PD., et al.[2023]
RELiZORB is a novel in-line digestive cartridge that effectively addresses the need for pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) receiving enteral nutrition, demonstrating compatibility with various formulas.
In clinical evaluations, RELiZORB was able to hydrolyze over 90% of fats in enteral nutrition formulas into absorbable fatty acids and monoglycerides, significantly improving fat absorption for patients who struggle with traditional long-chain triglycerides.
Options for addressing exocrine pancreatic insufficiency in patients receiving enteral nutrition supplementation.Freedman, SD.[2018]
In a study involving 15 male Yorkshire piglets with short bowel syndrome, the use of ALC-078 significantly improved the absorption of fat-soluble vitamins like vitamin D and E compared to untreated resected animals, indicating its potential efficacy in enhancing nutrient absorption.
ALC-078-treated piglets showed similar weight gain and fat absorption rates compared to those without intestinal resection, suggesting that it may help mitigate the effects of fat malabsorption in short bowel syndrome.
An in-line digestive cartridge increases enteral fat and vitamin absorption in a porcine model of short bowel syndrome.Tsikis, ST., Fligor, SC., Secor, JD., et al.[2023]

References

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. [2023]
Options for addressing exocrine pancreatic insufficiency in patients receiving enteral nutrition supplementation. [2018]
An in-line digestive cartridge increases enteral fat and vitamin absorption in a porcine model of short bowel syndrome. [2023]
Stated versus actual lipase activity in pancreatic enzyme supplements: implications for clinical use. [2019]
Clinical effectiveness of a pancreatic enzyme supplement. [2017]
Enzyme replacement therapy for pancreatic insufficiency: present and future. [2022]
Engineering a Remedy to Modulate and Optimize Biopharmaceutical Properties of Rebamipide by Synthesizing New Cocrystal: In Silico and Experimental Studies. [2022]
Rabeprazole for the treatment of acid-related disorders. [2013]
A potent preparation method combining neutralization with microfluidization for rebamipide nanosuspensions and its in vivo evaluation. [2016]
10.United Statespubmed.ncbi.nlm.nih.gov
Lansoprazole and ranitidine affect the accuracy of the 14C-urea breath test by a pH-dependent mechanism. [2022]
An open-label, parallel, multiple-dose study comparing the pharmacokinetics and gastric acid suppression of rabeprazole extended-release with esomeprazole 40 mg and rabeprazole delayed-release 20 mg in healthy volunteers. [2021]
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