Assessment of Combined Bowel Preparation for Capsule Endoscopy Study

Study Overview
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Brief Summary
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The investigators are conducting a study to see if taking a bowel preparation before having a capsule endoscopy is more helpful than the standard preparation of not eating after 7 PM the night before a capsule endoscopy in making it easier to see the small bowel in order to find the source of gastrointestinal bleeding.

Detailed Description
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This is a single-blind, prospective randomized controlled study to determine if a combination of purgative agent, prokinetic agent, simethicone, and position will improve small bowel visualization, diagnostic yield, and completion rate of capsule endoscopy.

Official Title
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Assessment of Combined Bowel Preparation for Capsule Endoscopy Study

Conditions
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Gastrointestinal Hemorrhage

Intervention / Treatment
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* Drug: Combination Prep


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years old Gastrointestinal bleeding as indication for capsule endoscopy. Ability to give informed consent Exclusion Criteria: Subject has an allergy to polyethylene glycol or other adverse reaction to a previous bowel preparation with PEG3350 (MoviPrep®), metoclopramide, or simethicone; Subjects has gastrointestinal motility disorder; Subjects had stomach or small bowel resection; Pregnancy; Subjects has pheochromocytoma; Subjects has uncontrolled hypertension; Subjects has seizure disorders; Subjects has concurrent MAO inhibitor use; Subject has G6PD deficiency; Subjects has swallowing disorder (including impaired gag reflex); Subjects has hyponatremia with serum sodium less than 130 mm0l/L

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard prep<br>One group will receive the standard bowel preparation, which consists of eating no solid foods after 7 p.m. the evening prior to the capsule endoscopy test and being able to consume clear liquids up to 4 hours prior to the capsule endoscopy test | |
| Active Comparator: Combination Prep<br>The other group will receive the combination bowel preparation, which consists of taking the standard bowel preparation plus: drinking 2-liters (8 cups) of polyethylene glycol starting at 7 p.m. the night prior to the capsule endoscopy test; drinking a teaspoon of simethicone 20 minutes prior to the capsule endoscopy test; drinking a teaspoon of metoclopramide 20 minutes prior to the capsule endoscopy test; lying on your right side for 30 minutes following the swallowing of the capsule endoscope. | Drug: Combination Prep<br>* combination bowel preparation, which consists of: drinking 2-liters (8 cups) of polyethylene glycol starting at 7 p.m. the night prior to the capsule endoscopy test; drinking a teaspoon of simethicone 20 minutes prior to the capsule endoscopy test; drinking a teaspoon of metoclopramide 20 minutes prior to the capsule endoscopy test; lying on your right side for 30 minutes following the swallowing of the capsule endoscope.<br>* Other names: metoclopramide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement small bowel visualization, diagnostic yield, and complete rate of capsule endoscopy | The primary endpoints of small bowel visualization quality, diagnostic yield, and completion rate will be compared between groups using Pearson's chi-square test. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety outcomes and Patient satisfaction | secondary endpoints of safety outcomes and patient satisfaction with Pearson's chi-square test. | 1 year | 
| gastric transit time | A group comparison for the secondary outcome of gastric transit time will be done using a two-sample t-test or Wilcoxon rank-sum test, as appropriate. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anemic, bleeding, blood in stool, abdomen pain, Gastrointestinal bleeding, capsule endoscopy (CE)