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

Benaroya Research Institute40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Colonoscopy

Interventions

Crystalline LactuloseDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Virginia Mason Medical Center

Seattle, Washington, United States

Outcomes

Primary Outcomes

Cleanliness of the Colon During Colonoscopy

To evaluate the primary objective of efficacy of the split-dose, the following endpoint will be measured: o Physician's determination of the cleanliness of the colon will be evaluated by completion of the Boston bowel prep scale.

Time frame: Day of the procedure

Secondary Outcomes

Treatment Failures

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).

Time frame: Day of the procedure

Patient Tolerability and Preference

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

Time frame: Day before and day of colonoscopy

Colonic Hydrogen and Methane Gas Production

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

Time frame: Day of colonoscopy

Safety/Adverse Events

To evaluate the secondary objective of safety as measured by the incidence of treatment emergent adverse events

Time frame: Day before colonoscopy till 7 days after colonoscopy

Data from ClinicalTrials.gov

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