Improving Tolerability of Bowel Preparation Laxative for Colonoscopy

September 13, 2018 updated by: Howard University

Comparison of Patterns of Laxative Ingestion to Improve Bowel Preparation for Colonoscopy: A Pilot Randomized Trial

The purpose of this study is to determine whether the pattern of flavoring and drinking of laxatives for colonoscopy can improve the experience of patients when they are undergoing bowel preparation for the test.

Investigators hypothesize that patients will have a better experience if patients taste the bowel preparation laxative with and without flavoring and then decide how they want to drink the rest of the laxative since taste preferences vary widely from person to person.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

313

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Howard University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults (18 years and older) referred for outpatient colonoscopy

Exclusion Criteria:

  • Patients with history of bowel resection
  • patients with history of inflammatory bowel disease
  • History of polyposis syndrome
  • History of colorectal cancer
  • History of poor taste perception from any cause

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Unflavored group
The patient will mix 1 gallon of polyethylene glycol with water and drink as directed by his/her endoscopist. No flavoring will be added.
Active Comparator: Flavored group
The patient will mix 1 gallon of polyethylene glycol with water, add flavoring to the entire solution and drink at the time specified by his/her endoscopist.
Other: Pattern of flavoring of bowel laxative
Unflavored bowel laxative versus entire bowel laxative flavored versus liberal flavoring as decided by patient
Active Comparator: Liberal group
The patient will mix 1 gallon of polyethylene glycol with water. Fill 2 cups with the solution. The patient will add flavoring to one cup and drink both the flavored and unflavored solutions in the cups. The patient will then determine how he/she wants to drink the rest of the bowel preparation laxatives based on their taste preference and drink at the time specified by his/her endoscopist.
Other: Pattern of flavoring of bowel laxative
Unflavored bowel laxative versus entire bowel laxative flavored versus liberal flavoring as decided by patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall patients' experience with the bowel preparation process with ratings from 1 (unbearable) to 10 (Pleasant)
Time Frame: At the time of colonoscopy
On the day of the patient's colonoscopy, each patient will complete another form regarding their bowel preparation experience. Information gathered will include their ratings of the bowel preparation laxative's taste, ease of consumption, presence or absence of nausea, vomiting, whether they consumed the entire recommended laxative and their overall ratings of the bowel preparation experience.
At the time of colonoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopist ratings of the patient's bowel preparation quality using Aronchick scale
Time Frame: At the colonoscopy
During the colonoscopy, the endoscopist who will be masked to the assignment of the patients will assess the quality of bowel preparation and grade as Poor/Inadequate, Fair, Good, Very Good or Excellent.
At the colonoscopy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of colorectal neoplasia (polyps, adenoma and cancer)
Time Frame: At the colonoscopy
The detection of colorectal lesions during colonoscopy (polyps, adenoma and cancer)
At the colonoscopy
Correlation of beverage intake patterns with tolerability of bowel laxatives
Time Frame: At the time of colonoscopy
Investigators will examine patients' preferred pattern of non-alcoholic beverage intake for coffee, tea and carbonated drinks with their bowel preparation experience
At the time of colonoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Howard University

Investigators

  • Principal Investigator: Adeyinka O Laiyemo, MD, MPH, Howard University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2014

Primary Completion (Actual)

January 21, 2015

Study Completion (Actual)

January 21, 2015

Study Registration Dates

First Submitted

February 11, 2014

First Submitted That Met QC Criteria

February 11, 2014

First Posted (Estimate)

February 13, 2014

Study Record Updates

Last Update Posted (Actual)

September 14, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-13-MED-60

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colonoscopy

Clinical Trials on Pattern of flavoring of bowel laxative

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe