Safety, Efficacy, and Patient Preference of Split-Dose Crystalline Lactulose as a Preparation for Colonoscopy in Adults

• Treatment Failures [ Time Frame: Day of the procedure ] [ Designated as safety issue: No ]

  To evaluate the secondary objective of efficacy, the following endpoint will be measured:

  o 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).

• Patient Tolerability and Preference [ Time Frame: Day before and day of colonoscopy ] [ Designated as safety issue: No ]
  To evaluate the secondary objective of patient tolerability and preference on the basis of the following assessments: Patient tolerability and preference questionnaire including 100 mm Visual Analog Scale (VAS) and Likert Scale
• Colonic Hydrogen and Methane Gas Production [ Time Frame: Day of colonoscopy ] [ Designated as safety issue: No ]

  To evaluate the secondary objective of measuring colonic hydrogen and methane gas production as measured by:

  o Colonic hydrogen and methane gas levels.

• Safety/Adverse Events [ Time Frame: Day before colonoscopy till 7 days after colonoscopy ] [ Designated as safety issue: Yes ]
  To evaluate the secondary objective of safety as measured by the incidence of treatment emergent adverse events

The purpose of this study is to determine the efficacy of a split-dose regimen of crystalline lactulose for cleansing of the colon as a preparation for colonoscopy, as assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Prep Scale (BBPS).

This is a single center, open-label, pilot study to determine the safety, efficacy, and patient preference of a split-dose regimen of Crystalline Lactulose for cleansing of the colon prior to colonoscopy. 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). Patient preference will be determined by the patient's responses on a patient questionnaire.

• Active Comparator: Evening Only (full-dose)
  The dosing regimen of Crystalline lactulose will be four 45-gram doses (one dose every 60 minutes for 4 straight hours) taken the evening before the colonoscopy procedure.
  Intervention: Drug: Crystalline Lactulose
• Experimental: Split-dose
  The dosing regimen of Crystalline lactulose will be three 45-gram doses (one dose every 60 minutes for 3 straight hours) taken the evening before the colonoscopy procedure followed by one 45-gram dose the morning before the colonoscopy procedure.
  Intervention: Drug: Crystalline Lactulose

Inclusion Criteria:

• Patients requiring bowel evacuation for colonoscopy

Exclusion Criteria:

• Patients with galactosemia (galactose-sensitive diet)
• Patients known to be hypersensitive to any of the components of Crystalline Lactulose
• Patients with a history of a failed bowel preparation
• Patients with severe constipation, defined as those patients taking daily prescription or over-the-counter laxatives
• Patients with possible bowel obstruction, previous colonic surgery, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus
• Patients on lactulose therapy or receiving any treatment for chronic constipation
• 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

• Virginia Mason Hospital/Medical Center
• Cumberland Pharmaceuticals