CClinicalTrials.gg
CompletedNCT03286764Updated Apr 3, 2020

Use of Peppermint Oil During Screening Colonoscopy to Improve Visibility

An interventional study of Peppermint Oil and Distilled water in Enhancement of the ADR During Colonoscopy, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-03.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Enhancement of the ADR During Colonoscopy
03

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Screening colonoscopy
  • Age 50 years and older
  • Able to give consent

Exclusion criteria

Exclusion Criteria:

  • 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
  • Known colorectal neoplasia
  • Non-correctable coagulopathy
  • Pregnancy or lactating
  • Prisoners
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Distilled water spray as a placebo during Colonoscopy

    Other: Distilled water

  • Experimental
    Peppermint Oil

    Peppermint Oil spray during Colonoscopy

    Other: Peppermint Oil

Interventions

  • OtherPeppermint Oil
  • OtherDistilled water

    Distilled water spray as a placebo during Colonoscopy

05

What researchers measure

Primary outcomes

  1. Determination of Adenoma Detection Rate during Colonoscopy Procedure

    Time frame: 2 hours

06

Study locations

1 site
  • Mayo Clinic in Arizona
    Scottsdale, Arizona 85259, United States
07

References and documents

08

Registry details

Key details

Study ID
NCT03286764
Lead sponsor
Mayo Clinic
Responsible party
Kevin C. Ruff, M.D. (PI, Mayo Clinic) — Principal investigator
First posted
Sep 18, 2017
Start date
Nov 2016
Primary completion
Sep 10, 2019
Completion
Sep 10, 2019
Last update
Apr 3, 2020

Study contacts

Kevin C Ruff
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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