Status:
COMPLETED
Congenital Sucrase-Isomaltase Deficiency (CSID) Genetic Prevalence Study (GPS)
Lead Sponsor:
QOL Medical, LLC
Collaborating Sponsors:
Arnold Palmer Hospital for Children
Baylor College of Medicine
Conditions:
Congenital Sucrase-isomaltase Deficiency (CSID)
Eligibility:
All Genders
Up to 18 years
Brief Summary
Congenital sucrose-isomaltase deficiency (CSID) is a rare, genetic disease in which mutations in the sucrose-isomaltase (SI) gene cause digestion problems of sucrose resulting in diarrhea and abdomina...
Eligibility Criteria
Inclusion
- Must be 18 years of age or younger.
- 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
- Any condition(s) or finding(s) that in the opinion of the principal investigator suggests an alternative diagnosis for his/her gastrointestinal symptoms.
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01914003
Start Date
May 1 2013
End Date
July 1 2015
Last Update
November 6 2017
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital Los Angeles
Los Angeles, California, United States
2
Children's Hospital and Research Center of Oakland
Oakland, California, United States
3
Children's Hospital of Colorado
Aurora, Colorado, United States
4
Arnold Palmer Children's Hospital
Orlando, Florida, United States