Efficacy of Lubiprostone Used With Polyethylene Glycol to Enhance Colonoscopy Preparation Quality in Diabetic Patients: A Randomized Single-Blind Controlled Trial
This is an investigator-initiated, single site (MCG only), single-blinded prospective study
comparing the efficacy of Lubiprostone and 4L PEG (Nulytely) to 4L PEG alone on preparation
quality in patients with known diabetes undergoing colonoscopy. Diabetic outpatients who
require a colonoscopy will be randomized to one of the two groups of 60 (total of 120
Control Group: All patients in the study will receive a standard oral 4L PEG colonoscopy
preparation the day prior to their scheduled colonoscopy.
Lubiprostone Group: The lubiprostone group will receive an additional two 24 mcg
lubiprostone capsules, which will be taken orally the morning and evening of the day of the
4L PEG prep (before and after the oral 4L PEG preparation).
Randomization Scheme: Subjects will be assigned to the Control Group or Lubiprostone Group,
on an odd/even basis. After research informed consent has been obtained, subjects are given
a study ID numbered 1 through 120. Subjects with an odd number will be assigned to Control
Group, and subjects with an even number will be assigned to the Lubiprostone Group.
Subjects then will be given a randomization package consisting of the preparation orders,
supplies, instructions and the date of their procedure by the investigator obtaining
informed consent. The colonoscopist will be blinded to which preparation was given.
Only diabetic patients who require an outpatient colonoscopy by a gastroenterologist at the
outpatient MCG Clinic will be eligible for the study. Patients will be presented with a
separate consent form for the colonoscopy procedure itself.
Standard of Care Procedures
- Colonoscopy Procedure Consent
- Research Informed Consent
- Disbursement of randomized preparation order and supplies, instructions, and date of
procedure to subjects
- Adverse Events
After the procedure, the physician who performed the colonoscopy will complete a form that
rates the quality of the subject's colonoscopy preparation on a 1-5 rating scale.
The subject's study participation duration is two days (day of preparation and day of
procedure). No follow-up visits will occur.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
The primary measured endpoint will be the quality of colonoscopy preparations as rated by blinded colonoscopists by a 5-point Likert Scale, and compared using the chi-square statistics.
End of study
Sherman M Chamberlain, MD
Georgia Regents University
United States: Food and Drug Administration
|Medical College of Georgia||Augusta, Georgia 30912|