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Our null hypothesis states that the two techniques (Sitzmarks radioopaque markers and SmartPill) are equivalent and is demonstrated if the study population shows a correlation of 0.7 or higher.
The purpose of the study is to measure total gastrointestinal transit time using SmartPill GI Monitoring System with pH.p Capsule and compare the transit time determined by capsule transit to the conventional radioopaque marker technique.
Both techniques are simultaneously applied in normal and constipated adult populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal | healthy adult subjects with no history or current gastrointestinal disorders or conditions | ||
| Constipated | Adult subjects with functional constipation as define by Rome II criteria |
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| Measure | Description | Time Frame |
|---|---|---|
| whole gut transit time | 2 days and 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Determine regional gut (gastric, small bowel, colonic) transit times | continuous time measure until caspule elimination |
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Inclusion Criteria:
Exclusion Criteria:
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patients with constipation referred to a tertiary motility center
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| Name | Affiliation | Role |
|---|---|---|
| Henry Parkman, MD | Temple University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic, Scottsdale | Scottsdale | Arizona | 85259 | United States | ||
| University of Iowa |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Iowa City |
| Iowa |
| 52242 |
| United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | United States |
| VA Medical Center | Buffalo | New York | 14215 | United States |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Temple University Medical Center | Philadelphia | Pennsylvania | 19140 | United States |