Kristalose as Bowel Evacuant Prior to Colonoscopy
Information source: Benaroya Research Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bowel Evacuant Prior to Colonoscopy
Intervention: Kristalose (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Benaroya Research Institute
Summary
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
Clinical Details
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
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Hydrogen and Methane Gas Production
Secondary outcome: Efficacy
Detailed description:
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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Patients requiring bowel evacuation for colonoscopy
Exclusion Criteria:
1. Patients with galactosemia (galactose-sensitive diet).
2. Patients known to be hypersensitive to any of the components of Kristalose.
3. Patients with possible bowel obstruction, previous colonic surgery, gastric
retention, bowel perforation, toxic colitis, toxic megacolon, or ileus.
4. Patients less than 18 years of age.
5. Inability to understand the requirements of the study or be unwilling to provide
written informed consent (as evidenced by signature on an informed consent document
approved by an Institutional Review Board [IRB]) and agree to abide by the study
restrictions.
6. Be pregnant or nursing
7. Be otherwise unsuitable for the study, in the opinion of the Investigator
Locations and Contacts
Virginia Mason Medical Center, Seattle, Washington 98101, United States
Additional Information
Starting date: December 2010
Last updated: October 5, 2011
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