Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)
NCT ID: NCT02598128
Last Updated: 2017-01-25
Study Results
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View full resultsBasic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2015-11-30
2016-06-30
Brief Summary
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Detailed Description
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1. In Period A (7 days), subjects will receive Peptamen 1.5 enteral feedings at home.
2. In Period B (11 days), subjects will be randomized to either Group A (active investigational then placebo control) or Group B (placebo control then active investigational) and receive Impact Peptide 1.5 on Days 1 and 9. During the 8-day washout period between Days 1 and 9, subjects will receive Peptamen 1.5.
3. In Period C (9 days), subjects will use RELiZORB during nocturnal enteral feedings with Impact Peptide 1.5.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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RELiZORB
Treatment (RELiZORB)
RELiZORB
Peptamen 1.5 received Period A and Period B (washout only). Impact Peptide 1.5 received Period B (Days 1 and 9 only) and Period C.
Control
Placebo control
Placebo
Sham device
Interventions
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RELiZORB
Peptamen 1.5 received Period A and Period B (washout only). Impact Peptide 1.5 received Period B (Days 1 and 9 only) and Period C.
Placebo
Sham device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Documented history of EPI
3. Enteral formula use minimum of 4x/week
4. Written informed consent or assent, as applicable
Exclusion Criteria
2. Signs and symptoms of liver cirrhosis or portal hypertension
3. Lung/liver transplant
4. Active cancer currently receiving cancer treatment
5. Crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerant, inflammatory bowel disease
6. DIOS or fibrosing colonopathy
4 Years
45 Years
ALL
No
Sponsors
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Alcresta Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Russell G. Clayton, Sr., DO
Role: STUDY_DIRECTOR
Chief Medical Officer, Alcresta Therapeutics, Inc.
Locations
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Children's Hospital of Los Angeles
Los Angeles, California, United States
St. Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States
Maine Medical Center
Portland, Maine, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Monroe Carell Junior Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Freedman S, Orenstein D, Black P, Brown P, McCoy K, Stevens J, Grujic D, Clayton R. Increased Fat Absorption From Enteral Formula Through an In-line Digestive Cartridge in Patients With Cystic Fibrosis. J Pediatr Gastroenterol Nutr. 2017 Jul;65(1):97-101. doi: 10.1097/MPG.0000000000001617.
Other Identifiers
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ALCT-0000497
Identifier Type: -
Identifier Source: org_study_id
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