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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist children with Short Bowel Syndrome (SBS). SBS hinders nutrient absorption, often requiring children to depend on intravenous (IV) nutrition, which can lead to serious complications. The trial explores a treatment called RELiZORB, a small device that aids in digesting fats in tube feedings, potentially reducing the need for IV nutrition. Children with SBS who require IV nutrition for more than half of their daily intake might be suitable candidates for this trial.

As an unphased trial, this study provides a unique opportunity for children to potentially benefit from an innovative treatment approach.

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 prior data suggests that this device is safe for children with malabsorption syndrome?

Research has shown that RELiZORB is safe and generally well-tolerated. Studies have demonstrated that it helps patients absorb fats better by breaking them down before they enter the body, particularly benefiting those with conditions like cystic fibrosis.

One study found no major side effects, indicating that RELiZORB is generally safe to use. Designed to work with feeding tubes, it is ideal for individuals who have trouble digesting fats. Overall, RELiZORB appears to improve nutrition without causing significant issues.12345

Why are researchers excited about this trial?

RELiZORB is unique because it is designed to enhance the digestion of fats directly within the feeding tube system, which is particularly beneficial for individuals with malabsorption syndrome. Unlike standard care options that often rely on enzyme pills or dietary modifications, RELiZORB uses an innovative cartridge that breaks down fats into absorbable fatty acids and monoglycerides before they enter the body. This method not only simplifies the process for individuals who rely on tube feeding but also aims to reduce dependency on parenteral nutrition, which is a more invasive and complex treatment. Researchers are excited about RELiZORB because it offers a more efficient and potentially more comfortable way to manage malabsorption, improving nutritional uptake directly at the source.

What evidence suggests that RELiZORB is effective for malabsorption syndrome?

Research has shown that RELiZORB, the treatment under study in this trial, helps people with digestion problems absorb fats more effectively. Studies found that RELiZORB use increases the amount of fatty acids in the blood, which are crucial for growth and energy. Patients using RELiZORB also reported fewer stomach issues, such as diarrhea, over time. Specifically, there was a noticeable improvement in growth, with steady increases in height and weight over a year. This suggests that RELiZORB is important for children with conditions that hinder fat absorption.12367

Who Is on the Research Team?

MP

Mark Puder, MD, PhD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Relizorb treatmentExperimental Treatment1 Intervention

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

🇺🇸
Approved in United States as RELiZORB for:

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+

Published Research Related to This Trial

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]
Cocrystallization of rebamipide with coformers like citric acid and oxalic acid significantly improved its solubility and bioavailability, achieving a 1.6-2.5 fold increase compared to pure rebamipide.
The new cocrystals not only enhanced the solubility and dissolution rate by 7-13 times but also showed improved anti-ulcer, anti-inflammatory, and antioxidant properties, indicating their potential as a more effective formulation for treating ulcers.
Engineering a Remedy to Modulate and Optimize Biopharmaceutical Properties of Rebamipide by Synthesizing New Cocrystal: In Silico and Experimental Studies.Jindal, A., Singh, R., Tomar, S., et al.[2022]
In a study of 23 adults with pancreatic insufficiency, pH-sensitive enteric-coated pancreatic lipase microspheres improved fat utilization to 76% compared to 63% with other enzyme supplements, indicating greater efficacy in nutrient absorption.
Over a year-long study with 22 patients, those using the microspheres gained an average of 4.0 kg and experienced a return to a near-normal lifestyle, highlighting both the safety and effectiveness of this treatment.
Clinical effectiveness of a pancreatic enzyme supplement.Valerio, D., Whyte, EH., Schlamm, HT., et al.[2017]

Citations

Development of a registry to evaluate immobilized lipase ...This prospective direct-to-patient observational registry collects real-world data regarding medical history, growth, quality of life, and progression towards ...
Absorption and Safety With Sustained Use of RELiZORB ...RELiZORB use was found to be safe, well tolerated, and resulted in increased levels of FAs in RBCs and plasma.
Proven to Hydrolyze Fats and Improve Fat Absorption 1No reported incidences of diarrhea at Day 90 · Overall, the number of participants reporting GI symptoms decreased from Day 30 to 90 · No participants ...
Alcresta Therapeutics Announces Enrollment of First ...Studies have demonstrated that RELiZORB is safe, well tolerated, and effective in improving fat absorption for patients with pancreatic ...
Evaluation of the Effectiveness of In‐line Immobilized ...Following use of immobilized lipase cartridge out to 12 months, patients experienced significantly steady increase in height and weight and ...
Absorption and Safety With Sustained Use of RELiZORB ...Protocol 0000498: Multicenter, open label study to evaluate the effect of sustained RELiZORB (immobilized lipase) cartridge use during enteral feeding on fat ...
Clinical StudiesResults from this study demonstrated that RELiZORB, when used per the intended use, was safe and well-tolerated and reduced signs of gastrointestinal ...
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