Peppermint oil for the treatment of Irritable Bowel Syndrome
- Conditions
- Irritable Bowel SyndromeAbdominal Pain
- Registration Number
- NL-OMON21220
- Lead Sponsor
- Maastricht University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 180
Inclusion Criteria
1. Age between 18 and 75 years;
2. Diagnosed with Irritable Bowel Syndrome according to the Rome III criteria:
Exclusion Criteria
1. Insufficient fluency of the Dutch language;
2. Any previous use (also incidental use) of peppermint oil capsules in the last 3 months prior to inclusion;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method As per FDA recommendation;<br /><br>1.Abdominal pain response rate after 8 weeks of treatment.<br /><br>a.A responder is defined as a patient who experiences at least a 30 percent decrease in the weekly average of worst daily abdominal pain (measured daily, on an 11 point NRS) compared to baseline weekly average in at least 50 percent of the weeks in which the treatment in given.<br><br /><br /><br>As per EMA recommendation;<br /><br>2.Degree of relief response rate after 8 weeks of treatment.<br /><br>a.A responder is defined as a patient who experiences a weekly relief of 1 or 2 (on a 7 point NRS) in at least 50 percent of the weeks in which treatment is given.
- Secondary Outcome Measures
Name Time Method