Assessment of Combined Bowel Preparation for Capsule Endoscopy Study

Gastrointestinal Hemorrhage Clinical Trial

— CEPREP  

Official title:

Assessment of Combined Bowel Preparation for Capsule Endoscopy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01243736
• Other study ID #: 10-000198
• Status: Completed
• Phase: Phase 1
• First received: October 19, 2010
• Last updated: January 19, 2016
• Start date: April 2010
• Est. completion date: November 2013

Study information

• Verified date: January 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage

Intervention

Drug:
• Combination Prep
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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety outcomes and Patient satisfaction	secondary endpoints of safety outcomes and patient satisfaction with Pearson's chi-square test.	1 year	Yes
Secondary	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	No