NCT01876576

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
Last Updated

June 12, 2013

Status Verified

June 1, 2013

Enrollment Period

8 months

First QC Date

June 10, 2013

Last Update Submit

June 11, 2013

Conditions

Colonic Diseases

Keywords

colonoscopy

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Efficacy - Individual colon segment cleansing Successful cleansing defined as BBPS score of 2 - 3 for a segment

    1 day (At colonoscopy)

Study Arms (2)

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

Clear liquidsOTHER

Clear liquids

clear liquids
Low residue breakfast and lunchOTHER

Low residue

low residue diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective outpatients \> 18 yrs undergoing colonoscopy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Colonic Diseases

Interventions

Lunch

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

MealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • David Kastenberg, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 12, 2013

Study Start

April 1, 2012

Primary Completion

December 1, 2012

Study Completion

April 1, 2013

Last Updated

June 12, 2013

Record last verified: 2013-06

Locations

US(1)