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| Name | Class |
|---|---|
| Virginia Mason Hospital/Medical Center | OTHER |
| Cumberland Pharmaceuticals | INDUSTRY |
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To determine whether Kristalose causes a significant increase in hydrogen and/or methane gas levels in patients requiring bowel evacuation, and also to determine the safety, efficacy, and patient preference of Kristalose as a bowel evacuant
This is a single center, open-label, pilot study to determine the safety, efficacy, and patient preference of Kristalose as a bowel evacuant prior to colonoscopy. Prior to colonoscopy, subjects will also undergo evaluation for the production of hydrogen and methane gases in the patient's gut (before and after receiving Kristalose) as assessed by a breath analysis instrument. Safety will be assessed by the occurrence of any treatment emergent adverse events. Efficacy will be determined by the endoscopist's rating of the cleanliness of the colon and the incidence of treatment failure (insufficient evacuation of the bowel).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kristalose | Experimental | Kristalose as Bowel Evacuant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kristalose | Drug | The dosing regimen of Kristalose will be nine 20-gram doses (one dose every 30 minutes for 4 straight hours) taken the evening before the colonoscopy procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hydrogen and Methane Gas Production | To evaluate the primary objective of hydrogen and methane gas production as measured by: • Pre- and post-dose breath analysis for hydrogen and methane gas. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | To evaluate the secondary objective of efficacy, the following endpoints will be measured:
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Inclusion Criteria:
Patients requiring bowel evacuation for colonoscopy
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
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| ID | Term |
|---|---|
| D007792 | Lactulose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| 3 months |
| D000073893 |
| Sugars |