Peppermint oil has shown to be effective in the treatment of Irritable Bowel Syndrome (IBS) symptoms in several meta-analyses. However, the level of evidence is moderate and peppermint oil remains relatively under-used in IBS. Therefore, the investigators will conduct a multicenter randomized, placebo controlled trial to investigate the effects of an eight-week peppermint oil treatment in IBS patients according to current European Medicines Agency (EMA) / US Food and Drug Administration (FDA) guidelines. To improve efficacy and to reduce side effects, the investigators aim to study the use of a new peppermint oil formulation, a colon-targeted-delivery capsule that will release the oil in the (ileo-) colonic region specifically.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
190
Peppermint oil, menthae piperitae aetheroleum
Placebo capsule, containing microcrystalline cellulose
Peppermint oil, menthae piperitae aetheroleum
Gelderse Vallei Hospital
Ede, Gelderland, Netherlands
Medical Center Leeuwarden
Leeuwarden, Provincie Friesland, Netherlands
Alrijne Hospital
Leiden, South Holland, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Abdominal pain response rate after 8 weeks of treatment
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.
Time frame: 8 weeks
Degree of relief response rate after 8 weeks of treatment.
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.
Time frame: 8 weeks
Global symptom improvement
As determined by IBS-SSS (IBS symptom severity scale)
Time frame: 8 weeks
Abdominal Discomfort
As determined by symptom diary
Time frame: 8 weeks
Bloating
As determined by IBS-SSS (IBS - symptom severity scale)
Time frame: 8 weeks
Regurgitation
As determined by symptom diary
Time frame: 8 weeks
Nausea
As determined by symptom diary
Time frame: 8 weeks
Urgency
As determined by symptom diary
Time frame: 8 weeks
Abdominal cramps
As determined by symptom diary
Time frame: 8 weeks
Average stool frequency and consistency
Measured by bristol stool chart
Time frame: 8 weeks
Indirect costs
Determined by Production Cost Questionnaire (PCQ) questionnaire
Time frame: 8 weeks, 3 and 6 months
Direct costs
Determined by Medical Cost Questionnaire (MCQ) questionnaire
Time frame: 8 weeks, 3 and 6 months
General Quality of Life
As determined by Euro-Qol-5D (EQ-5D)
Time frame: 8 weeks, 3 and 6 months
IBS related Quality of Life
As determined by IBS-Quality of life questionnaire (IBS-QoL)
Time frame: 8 weeks, 3 and 6 months
Use of Over the counter medication and rescue medication
Number of drugs taken as rescue medication (This is not an intervention)
Time frame: 8 weeks
Number and severity of side effects
Determined by daily diary
Time frame: 8 weeks
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
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