Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy

Introduction of small bowel capsule endoscopy made available an unique technique for
diagnostic evaluation of the gastrointestinal tract. After esophagogastroduodenoscopy and
colonoscopy about 5% of bleeding cases remain unexplained and capsule endoscopy provides
small bowel yield. Capsule endoscopy has special application for evaluation of inflammation
bowel disease and other small bowel conditions. Several adjuncts are used to enhance the
examination by improving cleansing preparation or propulsion. Metoclopramide, tegaserod,
simethicone, erythromycin, phosphates and PEG colon cleansing agents have been tried and
some show improved visualization or increased propulsion where more capsules reach to
colonic cecum while still recording within the limits of its 8 hour battery. Recently, our
group had an observational report of our experience showing that either full bowel cleansing
preparation or prokinetics such as metoclopramide or tegaserod enhanced visualization and
functioning capsule transit to the colon. Lubiprostone is a novel chloride channel
activator that increases intestinal fluid secretion and motility. It is FDA approved and
indicated for treatment of chronic idiopathic constipation.

This investigation is designed to compare lubiprostone and placebo for cleansing and
propulsion in preparation for capsule endoscopy. The FDA approved 24 mcg constipation dose
was chosen because other medications used in similar single dose in our pilot studies appear
effective.