The Impact of Diet Liberalization on Bowel Preparation for Colonoscopy

June 11, 2013 updated by: Thomas Jefferson University
This study will evaluate the expansion of dietary options from clear liquids the entire day to a low reside breakfast and lunch for patients prior to undergoing bowel preparation with MoviPrep® and its effect on preparation quality for colonoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the expansion of dietary options from clear liquids the entire day to a low reside breakfast and lunch for patients prior to undergoing bowel preparation with MoviPrep® and its effect on preparation quality for colonoscopy. MoviPrep® is a commercially available 2 liter bowel purgative for use before colonoscopy in adults 18 years of age or older that is comprised of polyethylene glycol-electrolyte solution (PEG-ELS) plus sodium sulfate, sodium ascorbate, and ascorbic acid.

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Elective outpatients > 18 yrs undergoing colonoscopy

Exclusion Criteria:

  • Unable or unwilling to give informed consent
  • Age < 18 years
  • Pregnant
  • Breast feeding
  • Gastroparesis - established or suspected
  • Pseudo-obstruction - established or suspected
  • Severe constipation (< 1 BM a week)
  • Bowel obstruction
  • Colon resection
  • Chronic nausea or vomiting
  • Known Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency
  • PEG allergy
  • Significant psychiatric illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: clear liquids
Clear liquids the day of bowel preparation up to 2.5 hrs before colonoscopy
Other: Clear liquids
Clear liquids
Active Comparator: low residue diet
Low residue breakfast and lunch up to 1pm; clear liquids thereafter up to 2.5 hrs before colonoscopy
Other: Low residue breakfast and lunch
Low residue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy - Overall bowel cleansing based on Boston Bowel Preparation Scale score BBPS score of 2-3 for each segment AND total score
Time Frame: 1 day (At colonoscopy)
1 day (At colonoscopy)

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy - Individual colon segment cleansing Successful cleansing defined as BBPS score of 2 - 3 for a segment
Time Frame: 1 day (At colonoscopy)
1 day (At colonoscopy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Investigators

  • Principal Investigator: David Kastenberg, MD, Thomas Jefferson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

June 10, 2013

First Submitted That Met QC Criteria

June 11, 2013

First Posted (Estimate)

June 12, 2013

Study Record Updates

Last Update Posted (Estimate)

June 12, 2013

Last Update Submitted That Met QC Criteria

June 11, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12D.247

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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