Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 abdominal pain. Children with chronic, idiopathic diarrhea or abdominal pain will have their sucrose-isomaltase gene assessed for a panel of known CSID mutations to determine the prevalence of these mutations in an enriched population and also determine functional deficiency using a breath test.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSID Mutations | Individual has one or more known CSID mutations. | ||
| Control | Individual does not have any known CSID mutations. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of CSID Genetic Variants | Prevalence of CSID genetic variants in subjects 18 years of age or younger with a primary symptom of chronic idiopathic diarrhea or chronic abdominal pain without constipation. | 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
18 years of age or younger experiencing chronic, idiopathic diarrhea or abdominal pain for at least 4 weeks.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | United States | |||
| Children's Hospital and Research Center of Oakland |
Not provided
| Label | URL |
|---|---|
| Study overview | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CSID Mutations | Individual has one or more known CSID mutations. |
| FG001 | Control | Individual does not have any known CSID mutations. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CSID Mutations | Individual has one or more known CSID mutations. |
| BG001 | Control | Individual does not have any known CSID mutations. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Prevalence of CSID Genetic Variants | Prevalence of CSID genetic variants in subjects 18 years of age or younger with a primary symptom of chronic idiopathic diarrhea or chronic abdominal pain without constipation. | Posted | Number | Participants | 1 year |
|
|
|
Monitoring for adverse events occurred throughout the study, but none were expected or reported as no study drug was involved and minimally invasive procedures were used to obtain genetic and breath samples.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CSID Mutations | Individual has one or more known CSID mutations. | 0 | 27 | 0 | 27 | ||
| EG001 | Control | Individual does not have any known CSID mutations. | 0 | 26 | 0 | 26 |
Not provided
Not provided
As outlined in each Clinical Trial Agreement between Sponsor and PI.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Smith, Director of One Patient Services | QOL Medical, LLC | 919-832-4949 | hsmith@onepatientservices.com |
| ID | Term |
|---|---|
| C538139 | Sucrase-isomaltase deficiency, congenital |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|