The Impact of Diet Liberalization on Bowel Preparation fo... | NCT01876576

Studies
The Impact of Diet Liberalization on Bowel Preparation for Colonoscopy

NCT01876576

Sponsor

Thomas Jefferson University

Status

Completed

Last Update Posted

Jun 12, 2013Estimated

Enrollment

175Actual

Phase

Not Applicable

Conditions

Colonic Diseases

Interventions

Clear liquids
Low residue breakfast and lunch

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Apr 2013Actual

First Submitted Date

Jun 10, 2013

First Submission Date that Met QC Criteria

Jun 11, 2013

First Posted Date

Jun 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2013

Last Update Posted Date

Jun 12, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

175Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
clear liquids	Active Comparator	Clear liquids the day of bowel preparation up to 2.5 hrs before colonoscopy	Other: Clear liquids
low residue diet	Active Comparator	Low residue breakfast and lunch up to 1pm; clear liquids thereafter up to 2.5 hrs before colonoscopy	Other: Low residue breakfast and lunch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clear liquids	Other	Clear liquids	clear liquids
Low residue breakfast and lunch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Kastenberg, MD	Thomas Jefferson University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thomas Jefferson University		Philadelphia	Pennsylvania	19107	United States

Condition Browse Module

MeSH Terms

ID	Term
D003108	Colonic Diseases

Ancestor Terms

ID	Term
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D062409	Lunch

Ancestor Terms

ID	Term
D062407	Meals
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided