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

Primary Purpose

Gastrointestinal Hemorrhage

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Combination Prep
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastrointestinal Hemorrhage focused on measuring anemic, bleeding, blood in stool, abdomen pain, Gastrointestinal bleeding, capsule endoscopy (CE)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard prep

Combination Prep

Arm 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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety outcomes and Patient satisfaction
secondary endpoints of safety outcomes and patient satisfaction with Pearson's chi-square test.
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.

Full Information

First Posted
October 19, 2010
Last Updated
January 19, 2016
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01243736
Brief Title
Assessment of Combined Bowel Preparation for Capsule Endoscopy Study
Acronym
CEPREP
Official Title
Assessment of Combined Bowel Preparation for Capsule Endoscopy Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Hemorrhage
Keywords
anemic, bleeding, blood in stool, abdomen pain, Gastrointestinal bleeding, capsule endoscopy (CE)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard prep
Arm Type
No Intervention
Arm 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
Arm Title
Combination Prep
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Combination Prep
Other Intervention Name(s)
polyethylene glycol, simethicone, metoclopramide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement small bowel visualization, diagnostic yield, and complete rate of capsule endoscopy
Description
The primary endpoints of small bowel visualization quality, diagnostic yield, and completion rate will be compared between groups using Pearson's chi-square test.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Safety outcomes and Patient satisfaction
Description
secondary endpoints of safety outcomes and patient satisfaction with Pearson's chi-square test.
Time Frame
1 year
Title
gastric transit time
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie L. Hansel, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth Rajan, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32419949
Citation
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.
Results Reference
derived

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Assessment of Combined Bowel Preparation for Capsule Endoscopy Study

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