The Impact of Diet Liberalization on Bowel Preparation for Colonoscopy

NCT ID: NCT01876576

Last Updated: 2013-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colonic Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

clear liquids

Clear liquids the day of bowel preparation up to 2.5 hrs before colonoscopy

Group Type ACTIVE_COMPARATOR

Clear liquids

Intervention Type OTHER

Clear liquids

low residue diet

Low residue breakfast and lunch up to 1pm; clear liquids thereafter up to 2.5 hrs before colonoscopy

Group Type ACTIVE_COMPARATOR

Low residue breakfast and lunch

Intervention Type OTHER

Low residue

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clear liquids

Clear liquids

Intervention Type OTHER

Low residue breakfast and lunch

Low residue

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Kastenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12D.247

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.