Assessment of Combined Bowel Preparation for Capsule Endoscopy Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-11-30

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.

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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.

Conditions

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Gastrointestinal Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Standard prep

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Combination Prep

The other group will receive the combination bowel preparation, which consists of taking the standard bowel preparation plus:

1. drinking 2-liters (8 cups) of polyethylene glycol starting at 7 p.m. the night prior to the capsule endoscopy test;
2. drinking a teaspoon of simethicone 20 minutes prior to the capsule endoscopy test;
3. drinking a teaspoon of metoclopramide 20 minutes prior to the capsule endoscopy test;
4. lying on your right side for 30 minutes following the swallowing of the capsule endoscope.

Group Type ACTIVE_COMPARATOR

Combination Prep

Intervention Type DRUG

combination bowel preparation, which consists of:

1. drinking 2-liters (8 cups) of polyethylene glycol starting at 7 p.m. the night prior to the capsule endoscopy test;
2. drinking a teaspoon of simethicone 20 minutes prior to the capsule endoscopy test;
3. drinking a teaspoon of metoclopramide 20 minutes prior to the capsule endoscopy test;
4. lying on your right side for 30 minutes following the swallowing of the capsule endoscope.

Interventions

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Combination Prep

combination bowel preparation, which consists of:

1. drinking 2-liters (8 cups) of polyethylene glycol starting at 7 p.m. the night prior to the capsule endoscopy test;
2. drinking a teaspoon of simethicone 20 minutes prior to the capsule endoscopy test;
3. drinking a teaspoon of metoclopramide 20 minutes prior to the capsule endoscopy test;
4. lying on your right side for 30 minutes following the swallowing of the capsule endoscope.

Intervention Type DRUG

Other Intervention Names

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polyethylene glycol simethicone metoclopramide

Eligibility Criteria

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Inclusion Criteria

1. Age \> 18 years old
2. Gastrointestinal bleeding as indication for capsule endoscopy.
3. Ability to give informed consent

Exclusion Criteria

1. Subject has an allergy to polyethylene glycol or other adverse reaction to a previous bowel preparation with PEG3350 (MoviPrep®), metoclopramide, or simethicone;
2. Subjects has gastrointestinal motility disorder;
3. Subjects had stomach or small bowel resection;
4. Pregnancy;
5. Subjects has pheochromocytoma;
6. Subjects has uncontrolled hypertension;
7. Subjects has seizure disorders;
8. Subjects has concurrent MAO inhibitor use;
9. Subject has G6PD deficiency;
10. Subjects has swallowing disorder (including impaired gag reflex);
11. Subjects has hyponatremia with serum sodium less than 130 mm0l/L

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No