Enhancement of the ADR During ColonoscopyNCT03286764
Use of Peppermint Oil During Screening Colonoscopy to Improve Visibility
A study testing Peppermint Oil and Distilled water in people with Enhancement of the ADR During Colonoscopy, run by Mayo Clinic at 1 site in United States.
Trial summary
The investigators hypothesize that spraying peppermint oil containing L-menthol onto the colonic mucosa during colonoscopy will relax smooth muscle allowing better colonic visualization. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Enhancement of the ADR During Colonoscopy
- What is being tested?
- Peppermint Oil and Distilled water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 10 Sep 2019
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Screening colonoscopy
- Age 50 years and older
- Able to give consent
Who cannot join
- No consent obtained or adult lacking capacity to consent
- Do not reach cecum on colonoscopy
- Renal impairment (defined as CrCl <30 ml/min)
- Allergy to study peppermint oil solution
- History of colon resection
- Inflammatory bowel disease
Show all 10Show fewer
- Known colorectal neoplasia
- Non-correctable coagulopathy
- Pregnancy or lactating
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesize that spraying peppermint oil containing L-menthol onto the colonic mucosa during colonoscopy will relax smooth muscle allowing better colonic visualization.
- Being tested
- Peppermint Oil, Distilled water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peppermint OilOther
Distilled waterOther
Distilled water spray as a placebo during Colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Distilled water spray as a placebo during Colonoscopy Receives: Other: Distilled water |
| Peppermint Oil | Experimental | Peppermint Oil spray during Colonoscopy Receives: Other: Peppermint Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Adenoma Detection Rate during Colonoscopy Procedure
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study startNov 2016
- Primary completion10 Sep 2019
- Study completion10 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhancement of the ADR During ColonoscopyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin C. Ruff, M.D., Mayo Clinic
- Investigators
- Kevin C Ruff, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286764
- Sponsor's protocol ID
- 14-006242
- Status last verified
- Apr 2020
- First submitted
- 15 Sep 2017
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Peppermint Oil During Screening Colonoscopy to Improve Visibility
- ClinicalTrials.gov ID
- NCT03286764
- Acronym / sponsor ID
- 14-006242
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 18 Sep 2017 (actual)
- 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 hypothesize that spraying peppermint oil containing L-menthol onto the colonic mucosa during colonoscopy will relax smooth muscle allowing better colonic visualization.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Distilled waterDistilled water spray as a placebo during Colonoscopy |
| Peppermint Oil | Experimental | Other: Peppermint OilPeppermint Oil spray during Colonoscopy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Screening colonoscopy
- Age 50 years and older
- Able to give consent
Key exclusion criteria (10 listed)
- No consent obtained or adult lacking capacity to consent
- Do not reach cecum on colonoscopy
- Renal impairment (defined as CrCl <30 ml/min)
- Allergy to study peppermint oil solution
- History of colon resection
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 |
|---|---|---|
| Peppermint Oil | Other | Peppermint Oil |
| Distilled waterDistilled water spray as a placebo during Colonoscopy | Other | Placebo |
Primary outcome
Determination of Adenoma Detection Rate during Colonoscopy Procedure
Time frame: 2 hours
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 3 Apr 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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.
Kevin C Ruff principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peppermint Oil and Distilled water in people with Enhancement of the ADR During Colonoscopy, run by Mayo Clinic at 1 site in United States.
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 3 inclusion and 10 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 3 Apr 2020. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Determination of Adenoma Detection Rate during Colonoscopy Procedure (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2020.