Kristalose as Bowel Evacuant Prior to Colonoscopy
| Status: | Archived |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | December 2010 |
A Single Center, Open-Label, Pilot Study to Determine the Safety, Efficacy, and Patient Preference of Kristalose as a Bowel Evacuant Prior to Colonoscopy
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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Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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