NCT03286764

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2019

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

2.9 years

First QC Date

September 15, 2017

Last Update Submit

April 2, 2020

Conditions

Enhancement of the ADR During Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Determination of Adenoma Detection Rate during Colonoscopy Procedure

    2 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Distilled water spray as a placebo during Colonoscopy

Other: Distilled water

Peppermint Oil

EXPERIMENTAL

Peppermint Oil spray during Colonoscopy

Other: Peppermint Oil

Interventions

Peppermint OilOTHER
Peppermint Oil
Distilled waterOTHER

Distilled water spray as a placebo during Colonoscopy

Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

MeSH Terms

Interventions

peppermint oil

Study Officials

  • Kevin C Ruff

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 15, 2017

First Posted

September 18, 2017

Study Start

November 1, 2016

Primary Completion

September 10, 2019

Study Completion

September 10, 2019

Last Updated

April 3, 2020

Record last verified: 2020-04

Locations

US(1)