Peppermint oil for the treatment of Irritable Bowel Syndrome: optimizing therapeutic strategies using targeted delivery - PERSUADE

Maastricht University0 sites178 target enrollmentStarted: March 9, 2016Last updated: June 30, 2019

Conditions

Drugs

Trial Snapshot

No summary available.

•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 (<55 years old) must use contraception or be postmenopausal for at least two years.
•5. Average worst abdominal pain score (on 11-point NRS) of > 3, during the two-week run-in period.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 140
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 38

•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.

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