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

Phase 4

Completed

Conditions: Inflammatory Bowel Disease

Interventions: Drug: Lubiprostone
Drug: Placebo

Registration Number: NCT00746395

Lead Sponsor: University of South Alabama

Brief Summary: This investigation is designed to compare lubiprostone and placebo for cleansing and propulsion in preparation for capsule endoscopy.

Detailed Description: 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 polyethylene glycol (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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 45

Inclusion Criteria

Healthy volunteers

Exclusion Criteria

Gi disorders, gi surgery, cardiac, renal, or hepatic insufficiency, severe diarrhea

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lubiprostone 24mcg single dose	Lubiprostone	lubiprostone 24mcg single dose po prior to capsule endoscopy
Sugar pill	Placebo	Placebo (sugar pill) - matched single dose po prior to capsule endoscopy

Primary Outcome Measures