Congenital Sucrase-Isomaltase Deficiency (CSID) Genetic Prevalence Study (GPS)
NCT ID: NCT01914003
Last Updated: 2017-11-06
Study Results
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View full resultsBasic Information
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COMPLETED
53 participants
OBSERVATIONAL
2013-05-31
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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CSID Mutations
Individual has one or more known CSID mutations.
No interventions assigned to this group
Control
Individual does not have any known CSID mutations.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* A primary clinical diagnosis of chronic idiopathic diarrhea or chronic abdominal pain for at least 4 weeks.
* English or Spanish speaking subjects and parent(s)/guardian only.
* Parental consent from one parent/guardian and also subject assent when appropriate based on individual IRB requirements.
Exclusion Criteria
* Abdominal pain primarily related to constipation.
* Suspected gastrointestinal infectious disease.
* No current use of sacrosidase (Sucraid® Oral Solution).
* Known gastrointestinal disease such as celiac disease.
* Prior consumption of an investigational medication within the last 4 weeks.
* Antibiotics in the last 2 weeks, and no history of viral gastroenteritis within that same period of time.
* Known Hepatitis B or C infection (positive HBsAg or HCV within 6 months of enrollment) or Subject-Pugh Class C liver disease of any cause, HIV infection, tuberculosis, Clostridia difficile co-infection, cancer or systemic infections.
* Severe neurologic impairment that would prevent them from reporting a history of abdominal pain.
* Receiving or received biologic therapies (including infliximab, adalimumab, natalizumab) within 3 months prior to or at enrollment.
* Present or past use of immune modulators therapy (e.g., azathioprine, 6MP, methotrexate).
* Planned or previous abdominal surgery (e.g., bowel resection).
* Subjects with severe, uncontrolled systemic diseases.
* Presence of clinical alarm signs, including hypotension, anemia requiring blood transfusions, altered mental status, or inability to tolerate food and/or fluids by mouth.
18 Years
ALL
No
Sponsors
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Arnold Palmer Hospital for Children
OTHER
Baylor College of Medicine
OTHER
Nationwide Children's Hospital
OTHER
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
University of Mississippi Medical Center
OTHER
Children's Hospital and Research Center at Oakland
UNKNOWN
Columbia University
OTHER
Children's Hospital Los Angeles
OTHER
Children's Hospital and Health System Foundation, Wisconsin
OTHER
Children's Center for Digestive Healthcare, LLC
UNKNOWN
Massachusetts General Hospital
OTHER
Duke University
OTHER
Johns Hopkins University
OTHER
Children's Hospital of Philadelphia
OTHER
Children's Mercy Hospital Kansas City
OTHER
Children's Hospital Colorado
OTHER
Riley Children's Hospital
UNKNOWN
Primary Children's Hospital
OTHER
State University of New York - Downstate Medical Center
OTHER
QOL Medical, LLC
INDUSTRY
Responsible Party
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Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital and Research Center of Oakland
Oakland, California, United States
Children's Hospital of Colorado
Aurora, Colorado, United States
Arnold Palmer Children's Hospital
Orlando, Florida, United States
Children's Center for Digestive Healthcare
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Johns Hopkins Children's Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Morgan Stanley Children's Hospital
New York, New York, United States
Stony Brook University
Stony Brook, New York, United States
Duke University Children's Hospital
Durham, North Carolina, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Texas Children's Hospital
Houston, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Related Links
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Study overview
Other Identifiers
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S2002
Identifier Type: -
Identifier Source: org_study_id