Clinical Trials Logo
  1. Home
  2. Inflammatory Bowel Disease
  3. NCT00746395

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

Inflammatory Bowel Disease Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00746395
Study type Interventional
Source University of South Alabama
Contact
Status Completed
Phase Phase 4
Start date April 2008
Completion date September 2008
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT03278912 - Natural History of Intestinal Inflammation in People With Primary Immune Dysregulations
Terminated NCT00061282 - Clotrimazole Enemas for Pouchitis in Children and Adults Phase 1/Phase 2
Recruiting NCT05579392 - A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis N/A
Completed NCT03264690 - Study to Observe the Change in Microbiome in Human Derived Sample and the Relation With Clinical Response Before and After the Anti-TNF Treatment in IBD Patients
Recruiting NCT02861053 - Inflammatory Bowel Disease : Could a Regular Physical Activity Reduce Patients Fatigue ? N/A
Recruiting NCT02275676 - Resting Energy Expenditure and Nutritional Status in IBD N/A
Completed NCT02503696 - Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD) N/A
Completed NCT02161640 - Vascular Dysfunction in Paediatric IBD N/A
Completed NCT02197780 - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD N/A
Completed NCT01852760 - Assessment of Disease Activity in Ulcerative Colitis by Endoscopic Ultrasound N/A
Completed NCT01860651 - Web-based Monitoring in Children and Adolescents With Inflammatory Bowel Disease N/A
Completed NCT01933867 - Water-aided Colonoscopy in Inflammatory Bowel Disease Patients N/A
Completed NCT01676324 - FOCUS: The Future of Fecal Calprotectin Utility Study for the Diagnosis and Management of Inflammatory Bowel Disease (IBD) N/A
Completed NCT01692743 - Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD) Phase 3
Completed NCT01688557 - Trial on Innovative Technologies in Colonoscopy N/A
Completed NCT01666535 - Infliximab IBD Influenza Vaccine Study N/A
Completed NCT01557387 - Real-time Diagnosis of Pseudopolyps During Colonoscopy
Completed NCT01981616 - Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab Phase 1
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT01221818 - A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of E6007 in Healthy Subjects Phase 1