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Kristalose as Bowel Evacuant Prior to Colonoscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01256541
First Posted: December 8, 2010
Last Update Posted: October 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Virginia Mason Hospital/Medical Center
Cumberland Pharmaceuticals
Information provided by:
Benaroya Research Institute
  Purpose
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

Condition Intervention Phase
Bowel Evacuant Prior to Colonoscopy Drug: Kristalose Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by Benaroya Research Institute:

Primary Outcome Measures:
  • Hydrogen and Methane Gas Production [ Time Frame: 3 months ]

    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.



Secondary Outcome Measures:
  • Efficacy [ Time Frame: 3 months ]

    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.[4]
    • 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).


Estimated Enrollment: 20
Study Start Date: December 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kristalose
Kristalose as Bowel Evacuant
Drug: Kristalose
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256541


Locations
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Benaroya Research Institute
Virginia Mason Hospital/Medical Center
Cumberland Pharmaceuticals
  More Information

Responsible Party: Otto Lin, MD, Virginia Mason Medical Center
ClinicalTrials.gov Identifier: NCT01256541     History of Changes
Other Study ID Numbers: IRB10068
First Submitted: December 7, 2010
First Posted: December 8, 2010
Last Update Posted: October 6, 2011
Last Verified: October 2011

Additional relevant MeSH terms:
Lactulose
Cathartics
Laxatives
Gastrointestinal Agents