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

NCT01541683 | Completed DMC

• 1 other identifier: IM.AS1.28
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colon Cancer

Keywords

PEG-electrolyte solution; bowel cleansing; Mentholyptus drops; Palatability

Outcome Measures

Primary Outcomes (1)

• measurement of Palatability of the PEG-electrolyte 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 Outcomes (2)

• volume remaining of the colon preparation solution

  1.5 hours after drinking the solution

• Side effects

  1.5 hours after drinking the solution

Study Arms (2)

Halls

EXPERIMENTAL

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®)

no Halls

OTHER

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®)

Interventions

PEG solution (Fortrans®) and Mentholyptus Drops (Halls®) OTHER

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®)

Halls

PEG solution (Fortrans®) OTHER

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)

no Halls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective colonoscopy
• consent to the study

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Beyrouth, 1107 2020, Lebanon

Location

Related Publications (1)

• Sharara AI, El-Halabi MM, Abou Fadel CG, Sarkis FS. Sugar-free menthol candy drops improve the palatability and bowel cleansing effect of polyethylene glycol electrolyte solution. Gastrointest Endosc. 2013 Dec;78(6):886-891. doi: 10.1016/j.gie.2013.05.015. Epub 2013 Jun 13.

  PMID: 23769143 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Ala I Sharara, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head and Professor, Division of Gastroenterology and Hepatology

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: March 1, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 7, 2013

Record last verified: 2013-08

Locations

LE (1)