Kristalose as 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
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single Center, Open-Label, Pilot Study to Determine the Safety, Efficacy, and Patient Preference of Kristalose as a Bowel Evacuant Prior to Colonoscopy|
- Hydrogen and Methane Gas Production [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
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.
- Efficacy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
To evaluate the secondary objective of efficacy, the following endpoints will be measured:
- Physician's determination of the cleanliness of the colon will be evaluated by completion of the Boston bowel prep scale.
- The number and percentage of patient's who by the physician's determination are considered treatment failures (patients with insufficient evacuation of the bowel=Boston bowel prep score < 5, and/or any colon segment score of 0).
|Study Start Date:||December 2010|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Kristalose as Bowel Evacuant
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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256541
|United States, Washington|
|Virginia Mason Medical Center|
|Seattle, Washington, United States, 98101|