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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Hemorrhage
• Intervention / Treatment: Drug: Combination Prep

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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
Active Comparator: Combination Prep; 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; 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: metoclopramide; polyethylene glycol; simethicone

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Stephanie L. Hansel, M.D., Mayo Clinic; Principal Investigator: Elizabeth Rajan, M.D., Mayo Clinic

Publications and helpful links

General Publications

• Hansel SL, Murray JA, Alexander JA, Bruining DH, Larson MV, Mangan TF, Dierkhising RA, Almazar AE, Rajan E. Evaluating a combined bowel preparation for small-bowel capsule endoscopy: a prospective randomized-controlled study. Gastroenterol Rep (Oxf). 2019 Oct 19;8(1):31-35. doi: 10.1093/gastro/goz054. eCollection 2020 Feb.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: October 19, 2010
• First Submitted That Met QC Criteria: November 17, 2010
• First Posted (Estimate): November 18, 2010

Study Record Updates

• Last Update Posted (Estimate): January 20, 2016
• Last Update Submitted That Met QC Criteria: January 19, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: bleeding; Gastrointestinal bleeding; anemic; blood in stool; abdomen pain; capsule endoscopy (CE)
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Antifoaming Agents; Emollients; Simethicone; Metoclopramide
• Other Study ID Numbers: 10-000198