Your session is about to expire
← Back to Search
Digestive Enzyme Cartridge
RELiZORB for Malabsorption Syndrome
N/A
Recruiting
Led By Mark Puder, MD, PhD.
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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).
Male or female patients, ages 2 years to 18 years, inclusive.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
Study Summary
This trial is testing a new way to give tube feedings to children with intestinal problems, in order to help them digest fats and avoid complications from intravenous nutrition.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, similar devices may cause issues at the site where they attach to the body, digestive discomfort from altered nutrient absorption patterns, or allergic reactions to materials in the cartridge.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have short bowel syndrome and need parenteral nutrition or have a significantly shorter bowel.
Select...
I am between 2 and 18 years old.
Select...
I use a feeding tube and can handle 10 ml/kg/day of nutrition through it.
Select...
I am between 2 and 18 years old and have been diagnosed with Short Bowel Syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effectiveness of the RELiZORB enzyme cartridge on the absorption of enteral nutrition based on PN calories
Secondary outcome measures
Effectiveness of the RELiZORB enzyme cartridge on the absorption of enteral nutrition based on body weight change
Trial Design
1Treatment groups
Experimental Treatment
Group I: Relizorb treatmentExperimental Treatment1 Intervention
Patients will have tube feeds placed through chamber and evaluate wean from parenteral nutrition
Find a Location
Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
761 Previous Clinical Trials
5,579,698 Total Patients Enrolled
7 Trials studying Short Bowel Syndrome
186 Patients Enrolled for Short Bowel Syndrome
Alcresta Therapeutics, Inc.Industry Sponsor
3 Previous Clinical Trials
115 Total Patients Enrolled
1 Trials studying Short Bowel Syndrome
32 Patients Enrolled for Short Bowel Syndrome
Mark Puder, MD, PhD.Principal Investigator - Boston Children's Hospital
Boston Children's Hospital, Lawrence General Hospital
Vanderbilt University School Of Medicine (Medical School)
Children'S Hospital (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I do not have an untreated blockage or narrowing in my intestines.I do not have severe stomach or bowel movement disorders.I or my guardian understand the study's needs and can attend all visits.My nutritional needs via parenteral nutrition have been stable for the last month.Your bilirubin levels are within the normal range for your age and are not concerning to the doctor.Your blood test shows high levels of triglycerides, over 400 mg/dL.I use a feeding tube and can handle 10 ml/kg/day of nutrition through it.I have undergone a surgery to lengthen my intestines.I have been using pancreatic enzymes in the last 30 days.I am between 2 and 18 years old.I do not have significant pancreatic or biliary disease.I had surgery for a gut condition over 3 months ago.I've been on IV nutrition providing most of my daily calories for 6+ months.I use a feeding tube and can handle 10 ml/kg/day of nutrition through it.I have been diagnosed with microvillus inclusion disease.I have not taken cisapride in the last 30 days.I am between 2 and 18 years old and have been diagnosed with Short Bowel Syndrome.My chronic liver disease is not caused by SBS but another condition.My nutritional formula is not compatible with RELiZORB.I have conditions like cystic fibrosis or genetic issues affecting my body's absorption.I started teduglutide or a similar medication less than 6 months ago.I haven't used growth hormone or glutamine supplements in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Relizorb treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are enrolled in this research endeavor?
"Affirmative. According to clinicaltrials.gov, this research initiative is currently looking for volunteers; it was initially posted on November 21st 2018 and the most recent update happened September 13th 2022. The study will enrol 32 individuals from one facility."
Answered by AI
Are there any open opportunities for enrollment in this clinical experiment?
"Affirmative. Clinicaltrials.gov displays that this trial, which was originally posted on November 21st 2018, is actively seeking participants for enrollment. A total of 32 patients will be recruited from a single medical facility."
Answered by AI
What type of person is best suited to participate in this medical study?
"To be considered for the trial, patients must have short bowel syndrome and fall into the 2-18 year age range. 32 candidates are expected to join this clinical investigation."
Answered by AI
Is there an age cap for admittance into this medical experiment?
"According to the requirements of this investigation, individuals aged 2-18 may be eligible for participation. Furthermore, there are 380 studies dedicated to minors and 993 that accommodate elderly patients."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
How old are they?
18 - 65
What site did they apply to?
Boston Children's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Boston Children's Hospital: < 48 hours
Average response time
- < 2 Days
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger