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

Completed · Phase 2

Conditions studied: Colonoscopy

In brief

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).

Key facts

Study ID: NCT01650870
Run by: Benaroya Research Institute
People needed: 40
Starts: 2012-07-01
Expected to finish: 2012-09-01
Last updated by the study team: 2014-08-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients requiring bowel evacuation for colonoscopy

You may not qualify if…

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

Where it is running

Virginia Mason Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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