The Impact of Diet Liberalization on Bowel Preparation for Colonoscopy

Colonic Diseases Clinical Trial

Official title:

The Impact of Diet Liberalization on Bowel Preparation for Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01876576
• Other study ID #: 12D.247
• Status: Completed
• Phase: N/A
• First received: June 10, 2013
• Last updated: June 11, 2013
• Start date: April 2012
• Est. completion date: April 2013

Study information

• Verified date: June 2013
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Colonic Diseases

Intervention

Other:
• Clear liquids
Clear liquids
• Low residue breakfast and lunch
Low residue

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Efficacy - Individual colon segment cleansing Successful cleansing defined as BBPS score of 2 - 3 for a segment		1 day (At colonoscopy)	No