MINT-C: L-Menthol Injection as a Novel Technique During Colonoscopy

• Sponsor: University Hospitals Cleveland Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02588248
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.1
• Patients Per Site Per Month: 75.6

Study Details

Study Description

Brief Summary

The primary objective of this double-blinded, prospective, randomized placebo-controlled study is to evaluate for change in endoscopic adenoma detection rates (ADR) with the use of peppermint oil solution vs placebo application during colonoscopy. The investigators hypothesize that ADR will be increased with the use of the peppermint oil solution and thus further reduce the risk of colon cancer by means of colonoscopy.

Condition or Disease	Intervention/Treatment	Phase
Colonic Polyps; Colon Cancer	Drug: Peppermint Oil; Other: Placebo	Phase 3

Detailed Description

Adult subjects who are undergoing colonoscopy for primary colorectal cancer screening or surveillance. The study will be carried out as a prospective, double-blinded, fully-masked randomized controlled trial. Prior to the trial entry, the participant's labs and medical record will be reviewed in the electronic records system. If the subject meets inclusion/exclusion criteria, he or she will be consented at bedside prior undergoing their scheduled procedure and receive standard care as otherwise. Experimental and placebo solution ingredients will be serially numbered and randomized in a 1:1 ratio using a variable block strategy and provided by the institutional investigational pharmacy. Research staff will draw up experimental or placebo solution in 4 syringes with a total of 20mL in each solution.

The solutions are identical in appearance and endoscopic delivery. To prevent olfactory detection of the peppermint oil solution an essential oil diffuser will be used in all endoscopy rooms using the same oil as in the experimental solution. Endoscopists will be instructed to deliver the contents of one syringe sprayed via the endoscope in the cecum and one in the sigmoid colon. The contents of the other two syringes are to be delivered at the discretion of the endoscopist. After the procedure, endoscopists and study participants will be surveyed to determine if blinding was effective and to assess patient comfort levels, respectively. The primary and secondary end points will be determined on an intention to treat basis.

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Diagnostic
• Official Title: L-Menthol Injection as a Novel Technique During Colonoscopy: The MINT-C Study
• Actual Study Start Date: Apr 27, 2017
• Actual Primary Completion Date: May 30, 2017
• Actual Study Completion Date: May 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Peppermint Oil Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol) Ingredients: 16mL of peppermint oil (provided by the NowFoods® company) 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution 1L prepackage sterile water 2.6mL of undyed simethicone	Drug: Peppermint Oil; During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640 mg of L-Menthol).; Other Names: L-Menthol
Placebo Comparator: Placebo Solution B) Placebo solution Ingredients: 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution 1L prepackage sterile water 2.6mL of undyed simethicone Instructions to prepare: Add tween and simethicone to sterile water. Then, shake vigorously. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe	Other: Placebo; During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B, also has 0 mg of L-Menthol).

Outcome Measures

Primary Outcome Measures

1. Adenoma Detection Rates [2 weeks]

   Evaluate for changes in adenoma detection rates with the use of intraluminal peppermint oil application vs sterile water application during colonoscopy.

Secondary Outcome Measures

1. Polyp Detection Rates [1 week .]

   Evaluate for changes in Polyp detection rates.

2. Procedure Time [immediate]

   Evaluate for changes in total procedure time, cecal intubation time, and withdrawal time with the use of intraluminal peppermint oil application vs sterile water application during colonoscopy.

3. Advanced Adenoma Detection Rates [2 weeks]

   Evaluate for changes in advanced adenoma detection rates with the use of intraluminal peppermint oil application vs placebo during coloscopy. Advanced adenoma will be define as an adenoma with significant villous features (>25%), size of 1.0 cm or more, high-grade dysplasia, or early invasive cancer.

4. Cancer Detection Rates [2 weeks]

   Evaluate for changes in cancer detection rates with the use of intraluminal peppermint oil application vs placebo during colonoscopy.

5. Patient Comfort Level Recorded on Post-procedure Survey [1 day]

   Evaluate for changes in reported patient comfort levels with the use of intraluminal peppermint oil application vs placebo during colonoscopy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. At least 50 years of age in Caucasians or 45 years of age in African-Americans.

2. Patients undergoing primary screening colonoscopy (either average risk or increased-risk) or surveillance colonoscopy after prior screening/surveillance colonoscopy.

3. Capable of understanding instructions, adhering to study schedules and requirements, and willing to provide informed consent.

Exclusion Criteria:

1. History of colectomy, partial or complete

2. Symptoms suggesting possible colorectal stenosis or cancer

3. Inflammatory bowel disease

4. Familial polyposis syndromes

5. History of, or current diagnosis of colorectal cancer

6. American Society of Anesthesia Physical Stats (ASA PS) score of IV or greater

7. Non-correctable coagulopathy

8. Currently receiving anti-thrombotic therapy, with an INR > 1.5

9. Poor prep, total BBPS score < 6, or any part of the colon < 2.

10. Patients with known allergy to peppermint oil or peppermint containing products.

11. Patients taking calcium channel blockers (Amlodipine, Nifedipine, Verapamil, Diltiazem, Dihydropyridine, Felodipine, etc).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• University Hospitals Cleveland Medical Center

Investigators

• Principal Investigator: Richard Wong, MD, University Hospitals Cleveland Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 21, 2018

More Information

Publications

None provided.

• Responsible Party: Richard C. K. Wong, MD., M.D., University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT02588248
• Other Study ID Numbers: 05-15-07
• First Posted: Oct 27, 2015
• Last Update Posted: Apr 19, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Richard C. K. Wong, MD., M.D., University Hospitals Cleveland Medical Center: Colon Cancer; Colonic Polyps; L-Menthol; C-Mint
• Additional relevant MeSH terms: Colonic Neoplasms; Colonic Polyps; Peppermint oil; Menthol

Study Results

Participant Flow

Recruitment Details

Day1 - patients undergoing screening and surveillance colonoscopy are pre-screened to evaluate if they meet inclusion criteria. Once identified patient is approached by study personnel to determine their willingness. If willing to participate will undergo written consent for participation. Patients will be followed up by telephone for adverse reactions at 24-48 hr, one week and one month after colonoscopy.

Pre-assignment Detail

Patients will be questioned regarding their allergy status specific to peppermint oil and this will be documented in the consent form and in the RedCap database. The patient must meet all inclusion and exclusion criteria and willing to participate in informed consent.

Arm/Group Title	Placebo	Peppermint Oil
Arm/Group Description	Solution B) Placebo solution Ingredients: 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution 1L prepackage sterile water 2.6mL of undyed simethicone Instructions to prepare: Add tween and simethicone to sterile water. Then, shake vigorously. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose =80 ml Solution B which contains 0 mg of L-Menthol).	Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol) Ingredients: 16mL of peppermint oil (provided by the NowFoods® company) 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution 1L prepackage sterile water 2.6mL of undyed simethicone Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg L-Menthol).
Period Title: Overall Study
STARTED	42	40
COMPLETED	38	37
NOT COMPLETED	4	3

Baseline Characteristics

Arm/Group Title	Placebo	Peppermint Oil	Total
Arm/Group Description	Solution B) Placebo solution Ingredients: 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution 1L prepackage sterile water 2.6mL of undyed simethicone Instructions to prepare: Add tween and simethicone to sterile water. Then, shake vigorously. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B ; with 0 mg of L-Methol).	Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol) Ingredients: 16mL of peppermint oil (provided by the NowFoods® company) 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution 1L prepackage sterile water 2.6mL of undyed simethicone Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg L-Menthol).	Total of all reporting groups
Overall Participants	38	37	75
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	28 73.7%	30 81.1%	58 77.3%
>=65 years	10 26.3%	7 18.9%	17 22.7%
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]	60.5 (6.75)	67.73 (8.8)	60.5 (7.77)
Sex: Female, Male (Count of Participants)
Female	21 55.3%	25 67.6%	46 61.3%
Male	17 44.7%	12 32.4%	29 38.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	38 100%	37 100%	75 100%

Outcome Measures

1. Primary Outcome

Title	Adenoma Detection Rates
Description	Evaluate for changes in adenoma detection rates with the use of intraluminal peppermint oil application vs sterile water application during colonoscopy.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peppermint Oil	Placebo
Arm/Group Description	Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol) Ingredients: 16mL of peppermint oil (provided by the NowFoods® company) 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution 1L prepackage sterile water 2.6mL of undyed simethicone Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg L-Menthol).	Solution B) Placebo solution Ingredients: 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution 1L prepackage sterile water 2.6mL of undyed simethicone Instructions to prepare: Add tween and simethicone to sterile water. Then, shake vigorously. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B ; 0 mg of L-Menthol)
Measure Participants	37	38
Adenoma Detected "Yes" Yes Adenoma Detected	19 50%	20 54.1%
Adenoma Detected "No"	18 47.4%	18 48.6%

2. Secondary Outcome

Title	Polyp Detection Rates
Description	Evaluate for changes in Polyp detection rates.
Time Frame	1 week .

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peppermint Oil	Placebo
Arm/Group Description	Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol) Ingredients: 16mL of peppermint oil (provided by the NowFoods® company) 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution 1L prepackage sterile water 2.6mL of undyed simethicone Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg L-Menthol).	Solution B) Placebo solution Ingredients: 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution 1L prepackage sterile water 2.6mL of undyed simethicone Instructions to prepare: Add tween and simethicone to sterile water. Then, shake vigorously. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B ; 0 mg of L-Menthol)
Measure Participants	37	38
Polyp detected "Yes"	30 78.9%	29 78.4%
Polyp detected "No"	7 18.4%	9 24.3%

3. Secondary Outcome

Title	Procedure Time
Description	Evaluate for changes in total procedure time, cecal intubation time, and withdrawal time with the use of intraluminal peppermint oil application vs sterile water application during colonoscopy.
Time Frame	immediate

Outcome Measure Data

Analysis Population Description

Note that total procedure time was not collected

Arm/Group Title	Peppermint Oil	Placebo
Arm/Group Description	Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol) Ingredients: 16mL of peppermint oil (provided by the NowFoods® company) 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution 1L prepackage sterile water 2.6mL of undyed simethicone Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg L-Mentol).	Solution B) Placebo solution Ingredients: 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution 1L prepackage sterile water 2.6mL of undyed simethicone Instructions to prepare: Add tween and simethicone to sterile water. Then, shake vigorously. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B ; 0 mg of L-Menthol).
Measure Participants	37	38
Cecal Intubation time in minutes	12.4	12.9
Withdraw Time in minutes	20.5	17.2

4. Secondary Outcome

Title	Advanced Adenoma Detection Rates
Description	Evaluate for changes in advanced adenoma detection rates with the use of intraluminal peppermint oil application vs placebo during coloscopy. Advanced adenoma will be define as an adenoma with significant villous features (>25%), size of 1.0 cm or more, high-grade dysplasia, or early invasive cancer.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

The data was not entered in the database in a format that would allow it to be collated according to the definition above. Also, some subjects did show more than one advanced adenoma.

Arm/Group Title	Peppermint Oil	Placebo
Arm/Group Description	Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol) Ingredients: 16mL of peppermint oil (provided by the NowFoods® company) 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution 1L prepackage sterile water 2.6mL of undyed simethicone Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg L-Menthol).	Solution B) Placebo solution Ingredients: 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution 1L prepackage sterile water 2.6mL of undyed simethicone Instructions to prepare: Add tween and simethicone to sterile water. Then, shake vigorously. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B, 0 mg of L-Menthol).
Measure Participants	37	38
Tubular Adenoma	19 50%	19 51.4%
Tubulovillous Adenoma	0 0%	0 0%
Villous Adenoma	0 0%	0 0%
Serrated Adenoma	1 2.6%	4 10.8%
Cancer	1 2.6%	1 2.7%
No Adenoma	18 47.4%	18 48.6%

5. Secondary Outcome

Title	Cancer Detection Rates
Description	Evaluate for changes in cancer detection rates with the use of intraluminal peppermint oil application vs placebo during colonoscopy.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peppermint Oil	Placebo
Arm/Group Description	Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol) Ingredients: 16mL of peppermint oil (provided by the NowFoods® company) 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution 1L prepackage sterile water 2.6mL of undyed simethicone Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg L-Menthol).	Solution B) Placebo solution Ingredients: 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution 1L prepackage sterile water 2.6mL of undyed simethicone Instructions to prepare: Add tween and simethicone to sterile water. Then, shake vigorously. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B, 0 mg of L-Methol).
Measure Participants	37	38
Cancer detected "Yes"	1 2.6%	1 2.7%
Cancer detected "No"	36 94.7%	37 100%

6. Secondary Outcome

Title	Patient Comfort Level Recorded on Post-procedure Survey
Description	Evaluate for changes in reported patient comfort levels with the use of intraluminal peppermint oil application vs placebo during colonoscopy.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peppermint Oil	Placebo
Arm/Group Description	Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol) Ingredients: 16mL of peppermint oil (provided by the NowFoods® company) 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution 1L prepackage sterile water 2.6mL of undyed simethicone Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg L-Menthol).	Solution B) Placebo solution Ingredients: 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution 1L prepackage sterile water 2.6mL of undyed simethicone Instructions to prepare: Add tween and simethicone to sterile water. Then, shake vigorously. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B; 0mg of L- Menthol).
Measure Participants	37	38
No Discomfort	17 44.7%	19 51.4%
Slight Discomfort	15 39.5%	15 40.5%
Moderate(bothersome)	5 13.2%	1 2.7%
Severe	0 0%	0 0%
Not available	0 0%	3 8.1%

Adverse Events

Time Frame	Patients were assessed day one after procedure, 24-48 after, one week and one month after procedure
Adverse Event Reporting Description	patients were assessed and graded by AE definitions adapted from the National Cancer Institute Common Terminology Criteria for Adverse Events. Grades 1 through 5. Data was stored in RedCap.
Arm/Group Title	Peppermint Oil		Placebo
Arm/Group Description	Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol) Ingredients: 16mL of peppermint oil (provided by the NowFoods® company) 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution 1L prepackage sterile water 2.6mL of undyed simethicone Peppermint Oil: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg Placebo).		Solution B) Placebo solution Ingredients: 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution 1L prepackage sterile water 2.6mL of undyed simethicone Instructions to prepare: Add tween and simethicone to sterile water. Then, shake vigorously. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe Placebo: During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg Placebo).
All Cause Mortality
	Peppermint Oil		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/38 (0%)
Serious Adverse Events
	Peppermint Oil		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/38 (0%)
Other (Not Including Serious) Adverse Events
	Peppermint Oil		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/37 (18.9%)		8/38 (21.1%)
Gastrointestinal disorders
bloating and cramping	1/37 (2.7%)	1	4/38 (10.5%)	4
Loss of appetite	1/37 (2.7%)	1	0/38 (0%)	0
cramping	1/37 (2.7%)	1	2/38 (5.3%)	2
bloating	2/37 (5.4%)	2	0/38 (0%)	0
constipation and bloating	0/37 (0%)	0	1/38 (2.6%)	1
constipation	0/37 (0%)	0	1/38 (2.6%)	1
heartburn	0/37 (0%)	0	1/38 (2.6%)	1
hemorrhoids	1/37 (2.7%)	1	0/38 (0%)	0
Skin and subcutaneous tissue disorders
bumps	1/37 (2.7%)	1	0/38 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.