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

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

Detailed Description
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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.

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

Conditions
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Inflammatory Bowel Disease

Intervention / Treatment
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* Drug: Lubiprostone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers Exclusion Criteria: Gi disorders, gi surgery, cardiac, renal, or hepatic insufficiency, severe diarrhea

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lubiprostone 24mcg single dose<br>lubiprostone 24mcg single dose po prior to capsule endoscopy | Drug: Lubiprostone<br>* 24 mcg oral administration<br>* Other names: Amitiza;|
| Placebo Comparator: Sugar pill<br>Placebo (sugar pill) - matched single dose po prior to capsule endoscopy | Drug: Placebo<br>* Oral administration<br>* Other names: Sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Small Bowel Transit | Percent of subjects with capsule passage through small bowel | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Small Bowel Transit | Small bowel transit time | Duration of the test - 8 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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capsule, endoscopy, prokinetic, lubiprostone, Normal, volunteers