Inclusion |
1. Provide signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments |
2. Be ambulatory, community dwelling, 18 to 80 years, inclusive |
3. Meet Rome IV diagnostic criteria for IBS |
4. Have IBS of at least moderate severity, i.e., have a score on the IBS-SSS of >175 (0–500) at the baseline visit* |
5. If the patient is on medications which affect the gastrointestinal tract or visceral sensation (e.g., tricyclic antidepressants, fiber, antispasmodics, etc.), they must be on a stable dose for at least 1 month prior to entering the study and for the duration of the study* |
*Participants will be allowed to rescreen once if they do not meet inclusion criteria #4 or #5 at the initial screening visit |
Exclusion |
1. Self-reported pregnancy or planned pregnancy within the next 2 months |
2. Have an established diagnosis of any concomitant bowel disturbance that would interfere with the assessment of efficacy or safety in the study (e.g., Hirschsprung’s disease, diverticulitis, colonic ischemia) |
3. Report warning symptoms (e.g., rectal bleeding, weight loss >10%, iron deficiency anemia, etc.) otherwise not explained |
4. Have undergone previous abdominal surgery to the intestines (with the exception of uncomplicated appendectomy, cholecystectomy, hysterectomy, or polypectomy >6 months prior to enrollment) |
5. Have a history of drug, excluding nicotine or caffeine, or alcohol abuse within 2 years of entry into the study |
6. Exhibit abnormalities on physical examination, unless judged to be clinically insignificant by the investigator. Such cases will be noted |
7. Current, within the past 30 days, therapeutic use of enteric-coated peppermint oil for the treatment of IBS |
8. Known or suspected peppermint or soybean oil allergy |
9. Severe acid reflux (>3 episodes of heartburn or regurgitation per day on average over a week) |
10. Inability to speak or read English |
11. Unable or unwilling to cooperate with the study protocol or considered by the investigator to be unsuitable for the study |