Kristalose as Bowel Evacuant Prior to Colonoscopy

Completed · Phase 1

Conditions studied: Bowel Evacuant Prior to Colonoscopy

In brief

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

Key facts

Study ID

NCT01256541

Run by

Benaroya Research Institute

People needed

20

Starts

2010-12-01

Expected to finish

2011-09-01

Last updated by the study team

2011-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients requiring bowel evacuation for colonoscopy

You may not qualify if…

• Patients with galactosemia (galactose-sensitive diet).
• Patients known to be hypersensitive to any of the components of Kristalose.
• Patients with possible bowel obstruction, previous colonic surgery, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus.
• Patients less than 18 years of age.
• 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.
• Be pregnant or nursing
• Be otherwise unsuitable for the study, in the opinion of the Investigator

Where it is running

• Virginia Mason Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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