Assessment of Combined Bowel Preparation for Capsule Endoscopy Study (CEPREP)

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Gastrointestinal Hemorrhage

Treatments: Drug: Combination Prep

Study type: Interventional

Funder types: Other

Identifiers

NCT01243736

10-000198

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Standard prep

No Intervention group

Description:

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

Combination Prep

Active Comparator group

Description:

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.

Treatment:

Drug: Combination Prep