Clinical trial · Interventional
L-Menthol Injection as a Novel Technique During Colonoscopy
L-Menthol Injection as a Novel Technique During Colonoscopy: The MINT-C Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor/Investigator has decided to close out the study
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colonic Polyps | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Peppermint Oil | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Peppermint Oil
- description
- Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol) Ingredients: 1. 16mL of peppermint oil (provided by the NowFoods® company) 2. 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 3. 1L prepackage sterile water 4. 2.6mL of undyed simethicone
- interventionNames
- Drug: Peppermint Oil
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Solution B) Placebo solution Ingredients: 1. 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 2. 1L prepackage sterile water 3. 2.6mL of undyed simethicone Instructions to prepare: 4. Add tween and simethicone to sterile water. Then, shake vigorously. 5. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe
- interventionNames
- Other: Placebo
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available