Assessment of Combined Bowel Preparation for Capsule Endoscopy Study

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.

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Key information

Conditions

Gastrointestinal Hemorrhage Abdominal Pain Digestive System Diseases Gastrointestinal Diseases Hemorrhage Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combination Prep

Drug

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.

Other names: polyethylene glycol, simethicone, metoclopramide

Primary outcomes

Improvement small bowel visualization, diagnostic yield, and complete rate of capsule endoscopy

Time frame: 1 year

The primary endpoints of small bowel visualization quality, diagnostic yield, and completion rate will be compared between groups using Pearson's chi-square test.

Secondary outcomes

Safety outcomes and Patient satisfaction

Time frame: 1 year

secondary endpoints of safety outcomes and patient satisfaction with Pearson's chi-square test.
gastric transit time

Time frame: 1 year

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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Acronym: CEPREP

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Nov 18, 2010
Registry last updated: Jan 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed