Colon CancerNCT01541683
The Effect of Mentholyptus Drops on the Palatability of PEG-Electrolyte Solution
A study testing PEG solution (Fortrans®) and Mentholyptus Drops (Halls®) and PEG solution (Fortrans®) in people with Colon Cancer, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- What is being tested?
- PEG solution (Fortrans®) and Mentholyptus Drops (Halls®) and PEG solution (Fortrans®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteLebanon
- Study dates
- Jan 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elective colonoscopy
- consent to the study
Who cannot join
- pregnant or lactating women
- age less than 18 years
- significant gastroparesis
- gastric outlet obstruction
- ileus
- known or suspected bowel obstruction or perforation
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Lebanon1 site
American University of Beirut Medical Center
Beirut, Beirut, 1107 2020
About this study
Official title: 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.
- Conditions
- Colon Cancer
- Being tested
- PEG solution (Fortrans®) and Mentholyptus Drops (Halls®), PEG solution (Fortrans®)
- Keywords
- PEG-electrolyte solution, bowel cleansing, Mentholyptus drops, Palatability
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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®)
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)
| Study group | Role | What they receive |
|---|---|---|
| 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®). Receives: 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) Receives: Other: PEG solution (Fortrans®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1.5 hours after drinking the solution
Secondary outcomes (2)
volume remaining of the colon preparation 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.
Measured: 1.5 hours after drinking the solution
Side effects
number of patients who experienced nausea, vomiting, bloating, abdominal cramps or headaches while drinking the solution.
Measured: 1.5 hours after drinking the solution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ala'a Sharara, American University of Beirut Medical Center
- Investigators
- Ala I Sharara, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541683
- Sponsor's protocol ID
- IM.AS1.28
- Status last verified
- Aug 2013
- First submitted
- 21 Feb 2012
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23769143
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mentholyptus Drops (Halls®) on the Palatability of PEG-Electrolyte Solution (FORTRANS®) in Colonoscopy Preparation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01541683
- Acronym / sponsor ID
- IM.AS1.28
- Conditions
- Colon Cancer
- Keywords
- PEG-electrolyte solution, bowel cleansing, Mentholyptus drops, Palatability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 1 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Halls | Experimental | Other: PEG solution (Fortrans®) and Mentholyptus Drops (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®). |
| no Halls | Other | Other: PEG solution (Fortrans®)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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elective colonoscopy
- consent to the study
Key exclusion criteria (18 listed)
- pregnant or lactating women
- age less than 18 years
- significant gastroparesis
- gastric outlet obstruction
- ileus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Halls |
| 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) | Other | no Halls |
Primary outcome
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
2 secondary outcomes
volume remaining of the colon preparation solution
Time frame: 1.5 hours after drinking the solution
Side effects
Time frame: 1.5 hours after drinking the solution
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- Derived from this study: PubMed 23769143Sharara 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ala I Sharara, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEG solution (Fortrans®) and Mentholyptus Drops (Halls®) and PEG solution (Fortrans®) in people with Colon Cancer, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of Palatability of the PEG-electrolyte solution (time frame: 1.5 hours after drinking the solution). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01541683, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.