Irritable Bowel Syndrome Abdominal Pain
Conditions
Interventions
Arm 1: enteric-coated Peppermint Oil capsules
Arm 2: colon-targeted-delivery Peppermint Oil capsules
Arm 3: Placebo
Sponsors
Maastricht University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years; 2. Diagnosed with Irritable Bowel Syndrome according to the Rome III criteria: • Recurrent abdominal pain or discomfort, at least 3 days/month for the last 3 months; • Symptom onset at least 6 months prior to diagnosis • Associated with two or more of the following: 1. Improvement with defecation; 2. Onset associated with a change in frequency of stool; 3. Onset associated with a change in form (appearance/consistency) of stool; 3. Based on the medical history and previous examination, no other causes for the abdominal complaints can be defined. Especially no history of: a. Inflammatory Bowel Disease; b. Celiac Disease; c. Thyroid dysfunction (if not well-regulated); If alarm symptoms (including unexplained rectal blood loss or weight loss) are present, a colonoscopy has been performed and was negative for other causes. 4. Women in fertile age ( 3, during the two-week run-in period.
Exclusion 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; 3. The inability to stop regular use of medication affecting the gastro-intestinal system (such as Non Steroidal Anti Inflammatory Drugs (NSAID), laxatives, prokinetics, opioids, smasmolytics and anti-diarrhoeal drugs); a. The use of 1 antidepressant drug is allowed, providing dosing has been stable for > 6 weeks before enrollment; b. The use of 1 proton pump inhibitors (PPI) is allowed, providing dosing has been stable > 6 weeks before enrollment; 4. Previous major abdominal surgery or radiotherapy interfering with gastrointestinal function: a. Uncomplicated appendectomy, cholecystectomy and hysterectomy allowed unless within the past 6 months; b. Other surgery upon judgment of the principle investigator; 5. History of liver disease, cholangitis, achlorhydria, gallstones or other diseases of the gallbladder/biliary system; 6. Pregnancy, lactation; 7. Using drugs of abuse; 8. Known allergic reaction to peppermint.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As per FDA recommendation; 1.Abdominal pain response rate after 8 weeks of treatment. 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. As per EMA recommendation; 2.Degree of relief response rate after 8 weeks of treatment. 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
| Measure | Time frame |
|---|---|
| Global symptom improvement [Time Frame: 8 weeks] As determined by IBS-SSS (IBS symptom severity scale) Abdominal Discomfort [Time Frame: 8 weeks] As determined by symptom diary Bloating [Time Frame: 8 weeks] As determined by IBS-SSS (IBS - symptom severity scale) Regurgitation [Time Frame: 8 weeks] As determined by symptom diary Nausea [Time Frame: 8 weeks] As determined by symptom diary Urgency [Time Frame: 8 weeks] As determined by symptom diary Abdominal cramps [Time Frame: 8 weeks] As determined by symptom diary Average stool frequency and consistency [Time Frame: 8 weeks] Measured by bristol stool chart Indirect costs [Time Frame: 8 weeks, 3 and 6 months] Determined by Production Cost Questionnaire (PCQ) questionnaire Direct costs [Time Frame: 8 weeks, 3 and 6 months] Determined by Medical Cost Questionnaire (MCQ) questionnaire General Quality of Life [Time Frame: 8 weeks, 3 and 6 months] As determined by Euro-Qol-5D (EQ-5D) IBS related Quality of Life [Time Frame: 8 weeks, 3 and 6 months] As determined by IBS-Quality of life questionnaire (IBS-QoL) Use of Over the counter medication and rescue medication [Time Frame: 8 weeks] Number of drugs taken as rescue medication (This is not an intervention) Number and severity of side effects [Time Frame: 8 weeks] Determined by daily diary Responder rates following discontinuation of treatment at 3 and 6 months, different thresholds for the responder analysis of abdominal pain (e.g. 40 and 50 percent improvement); [Time Frame: 3 and 6 months after discontinuation of treatment] Responder rates when missing are interpreted as "no effect" [Time Frame: 8 weeks] | — |
Contacts
Public Contact- Persuade
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Outcome results
None listed