The Impact of Diet Liberalization on Bowel Preparation for Colonoscopy

Not Applicable

Completed

• Conditions: Colonic Diseases

• Registration Number: NCT01876576
• Lead Sponsor: Thomas Jefferson University

Brief Summary

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.

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 Timeline

• Study Start: 2012-04
• Primary Completion: 2012-12
• Study Completion: 2013-04
• Status Verified: 2013-06
• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-06-11
• Last Update Submitted: 2013-06-11
• Study First Posted: 2013-06-12
• Last Update Posted: 2013-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Efficacy - Individual colon segment cleansing Successful cleansing defined as BBPS score of 2 - 3 for a segment	1 day (At colonoscopy)

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States