The Effect of Mentholyptus Drops on the Palatability of PEG-Electrolyte Solution

August 5, 2013 updated by: Ala'a Sharara, American University of Beirut Medical Center

The Effect of Mentholyptus Drops (Halls®) on the Palatability of PEG-Electrolyte Solution (FORTRANS®) in Colonoscopy Preparation: A Randomized Controlled Trial

The investigators aim is to study the efficacy of mentholyptus drops in improving the palatability of PEG-electrolyte solution used in bowel cleansing for colonoscopy. The study is a randomized controlled trial which will include patients undergoing elective colonoscopy at the American University of Beirut Medical Center. Patients will be randomized into one of two study arms using a computer generated randomization list. Patients assigned to the intervention arm will be asked to have candy (Halls®) during the whole 2 hours period while drinking the PEG solution unlike the control arm patients who will only receive the PEG solution. All patients will then be evaluated for the tolerability of the preparation while taking into account the palatability of the solution as main outcome and the remaining volume of the PEG solution and side effects as secondary outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

99

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

  • Lebanon
      • Beirut, Lebanon, 1107 2020
        • American University of Beirut Medical Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective colonoscopy
  • consent to the study

Exclusion Criteria:

  • pregnant or lactating women
  • age less than 18 years
  • significant gastroparesis
  • gastric outlet obstruction
  • ileus
  • known or suspected bowel obstruction or perforation
  • phenylketonuria
  • glucose-6-phosphate dehydrogenase deficiency
  • severe chronic renal failure (creatinine clearance <30 mL/minute)
  • severe congestive heart failure (NYHA class III or IV)
  • dehydration
  • severe acute inflammatory disease
  • compromised swallowing reflex or mental status
  • uncontrolled hypertension (systolic blood pressure ≥170 mm Hg, diastolic blood pressure ≥100 mm Hg)
  • toxic colitis or megacolon
  • previous colonoscopy within the last 5 years
  • active Inflammatory bowel disease
  • previous colectomy or partial colectomy

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Halls
every patient will drink 4 Liters of PEG solution (FORTRANS®) split into 2 days with sugar-free mentholyptus drops (2 L at 7-9 pm on the day prior to the colonoscopy with Halls®, and 2 L on the day of the colonoscopy to be completed a minimum of 1.5 hours before the procedure with Halls®).
Other: PEG solution (Fortrans®) and Mentholyptus Drops (Halls®)
Patients will be instructed to drink 4 Liters of PEG solution (FORTRANS®) split into 2 days while sucking on sugar-free mentholyptus drops (2 L at 7-9 pm on the day prior to the colonoscopy while continuously sucking on Halls®, and 2 L on the day of the colonoscopy to be completed a minimum of 1.5 hours before the procedure while continuously sucking on Halls®)
Other: no Halls
Every patient will drink 4 liters of PEG solution (FORTRANS®) split into 2 days (2 L at 7-9 pm on the day prior to the colonoscopy, and 2 L on the day of the colonoscopy to be completed a minimum of 1.5 hours before the procedure)
Other: PEG solution (Fortrans®)
4 liters of PEG solution (FORTRANS®) split into 2 days (2 L at 7-9 pm on the day prior to the colonoscopy, and 2 L on the day of the colonoscopy to be completed a minimum of 1.5 hours before the procedure)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of Palatability of the PEG-electrolyte solution
Time Frame: 1.5 hours after drinking the solution
patients will be asked to assess the palatability of the colon preparation solution (Fortrans®) by giving it a score on a scale from 1 to 5 with 1 being disgusting and 5 being tasty after drinking the whole solution and immediately prior to the colonoscopy
1.5 hours after drinking the solution

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
volume remaining of the colon preparation solution
Time Frame: 1.5 hours after drinking the solution
Patients will be asked to bring with them to the endoscopy suit the volume remaining, if any, of the colon preparation solution that they were not able to drink. The volume remaining will be measured by the research fellow using a graduated cylinder.
1.5 hours after drinking the solution
Side effects
Time Frame: 1.5 hours after drinking the solution
number of patients who experienced nausea, vomiting, bloating, abdominal cramps or headaches while drinking the solution.
1.5 hours after drinking the solution

Collaborators and Investigators

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

Sponsor

American University of Beirut Medical Center

Investigators

  • Principal Investigator: Ala I Sharara, MD, American University of Beirut Medical Center

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

January 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

February 21, 2012

First Submitted That Met QC Criteria

February 29, 2012

First Posted (Estimate)

March 1, 2012

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 5, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM.AS1.28

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 Colon Cancer

Clinical Trials on PEG solution (Fortrans®) and Mentholyptus Drops (Halls®)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe