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New treatment option for Short Bowel Syndrome
Official title A 90 Day, Phase 3,Open Labeled Exploratory Study of RELiZORB
ClinicalTrials.gov ID: NCT03530852
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 18
You may be able to join if
- 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...
- 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
- 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...
You likely can't join if
- Other causes of chronic liver disease other than SBS (i.e., hepatitis C, cystic fibrosis, biliary atresia, alpha 1 anti-trypsin deficiency, and...
- 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.
- Evidence of untreated intestinal obstruction or active stenosis, as determined by the investigator.
- Unstable absorption due to cystic fibrosis or known DNA abnormalities (i.e., familial adenomatous polyposis, Fanconi syndrome) as determined by the...
See the full eligibility criteria
Who can join
- 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
- 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.
- The patient has a Central Venous Catheter (CVC) at the time of study inclusion.
- Screening direct bilirubin that is in the normal range for age and is not determined to be clinically significant by the investigator.
- The patient has an existing feeding tube, receiving enteral nutrition via an enteral feeding pump at a rate\>10ml/hr but \<400 ml/hr, and is able to tolerate at least 10 ml/kg/day enteral nutrition with which the...
- Stable enteral nutrition requirement with no change in formula composition or rate for at least 1 month prior to screening.
- The parent or legal guardian of the patient is able to read, understand, and is willing to provide informed consent (and assent, if applicable).
- 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...
- A parent or legal guardian is willing to provide written authorization for the use and disclosure of protected health information.
What rules you out
- 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.
- Evidence of untreated intestinal obstruction or active stenosis, as determined by the investigator.
- Unstable absorption due to cystic fibrosis or known DNA abnormalities (i.e., familial adenomatous polyposis, Fanconi syndrome) as determined by the investigator.
- History of microvillus inclusion disease, as determined by medical history.
- Severe known dysmotility syndrome (i.e., pseudo-obstruction, gastroschisis-related motility disorders), as determined by the investigator.
- Initiation of teduglutide or other GLP-2 analogues within 6 months of screening
- Use of growth hormone, or supplemental glutamine within 3 months prior to screening.
- Use of cisapride within 30 days prior to screening.
- Active clinically significant pancreatic or biliary disease, as determined by the investigator.
- Patients are receiving formulas that are not compatible with the RELiZORB cartridge (example, insoluble fiber-containing formulas)
- Determined by the investigator to be unsuitable for participation for any reason.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.