Kristalose as Bowel Evacuant Prior to Colonoscopy

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

Study Overview

• Status: Completed
• Conditions: Bowel Evacuant Prior to Colonoscopy
• Intervention / Treatment: Drug: Kristalose

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).

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hydrogen and Methane Gas Production	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	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).	3 months

Collaborators and Investigators

• Sponsor: Benaroya Research Institute
• Collaborators: Cumberland Pharmaceuticals; Virginia Mason Hospital/Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): September 1, 2011

Study Registration Dates

• First Submitted: December 7, 2010
• First Submitted That Met QC Criteria: December 7, 2010
• First Posted (ESTIMATE): December 8, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 6, 2011
• Last Update Submitted That Met QC Criteria: October 5, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Lactulose
• Other Study ID Numbers: IRB10068