Peppermint Oil for the Treatment of Irritable Bowel Syndrome: Optimizing Therapeutic Strategies Using Targeted Delivery (PERSUADE)
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ClinicalTrials.gov Identifier: NCT02716285 |
Recruitment Status :
Completed
First Posted : March 23, 2016
Last Update Posted : November 2, 2018
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Condition or disease | Intervention/treatment | Phase |
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Irritable Bowel Syndrome Abdominal Pain Colonic Diseases, Functional | Drug: Ileocolonic release peppermint oil Drug: Placebo Drug: Small intestinal release peppermint oil | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 190 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Peppermint Oil for the Treatment of Irritable Bowel Syndrome: Optimizing Therapeutic Strategies Using Targeted Delivery |
Actual Study Start Date : | August 17, 2016 |
Actual Primary Completion Date : | May 1, 2018 |
Actual Study Completion Date : | October 1, 2018 |

Arm | Intervention/treatment |
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Experimental: Ileocolonic release peppermint oil
Colon-targeted-delivery capsule containing 182mg of Peppermint Oil, to be taken orally, 3 times daily for 8 weeks (first week, dosing will be titred).
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Drug: Ileocolonic release peppermint oil
Peppermint oil, menthae piperitae aetheroleum |
Experimental: Small intestinal release peppermint oil (Tempocol®)
Enteric-coated capsule containing 182mg of Peppermint Oil that release the oil in the small intestine, to be taken orally, 3 times daily for 8 weeks (first week, dosing will be titred).
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Drug: Small intestinal release peppermint oil
Peppermint oil, menthae piperitae aetheroleum
Other Name: Tempocol |
Placebo Comparator: Placebo
Capsule containing microcrystalline cellulose, to be taken orally, 3 times daily for 8 weeks (first week, dosing will be titred).
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Drug: Placebo
Placebo capsule, containing microcrystalline cellulose |
- Abdominal pain response rate after 8 weeks of treatment [ Time Frame: 8 weeks ]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.
- Degree of relief response rate after 8 weeks of treatment. [ Time Frame: 8 weeks ]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.
- 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 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age between 18 and 75 years;
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Diagnosed with Irritable Bowel Syndrome according to the Rome IV criteria:
(Recurrent abdominal pain, at least 1 day/week for the last 3 months; Symptom onset at least 6 months prior to diagnosis; Associated with two or more of the following:
- Pain related to defecation;
- Pain associated with a change in frequency of stool;
- Pain associated with a change in form (appearance/consistency) of stool
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Based on the medical history and previous examination, no other causes for the abdominal complaints can be defined. Especially no history of:
- Inflammatory Bowel Disease;
- Celiac Disease;
- 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.
- Women in fertile age (<55 years old) must use contraception or be postmenopausal for at least two years.
- Average worst abdominal pain score (on 11-point NRS) of > 3, during the two-week run-in period.
Exclusion Criteria:
- Insufficient fluency of the Dutch language;
- Any previous use (also incidental use) of peppermint oil capsules in the last 3 months prior to inclusion (the use of peppermint tea, menthol candy etc. is allowed);
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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). This use should be halted at least 1 week before enrollment into the run-in period;
- The use of 1 antidepressant drug is allowed, providing dosing has been stable for > 6 weeks before enrollment;
- The use of 1 proton pump inhibitor (PPI) is allowed, providing dosing has been stable > 6 weeks before enrollment;
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Previous major abdominal surgery or radiotherapy interfering with gastrointestinal function:
- Uncomplicated appendectomy, cholecystectomy and hysterectomy allowed unless within the past 6 months;
- Other surgery upon judgment of the principle investigator;
- History of liver disease, cholangitis, achlorhydria, gallstones or other diseases of the gallbladder/biliary system;
- Pregnancy, lactation;
- Using drugs of abuse;
- Known allergic reaction to peppermint.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716285
Netherlands | |
Medical Center Leeuwarden | |
Leeuwarden, Friesland, Netherlands, 8934 AD | |
Gelderse Vallei Hospital | |
Ede, Gelderland, Netherlands, 6716 RP | |
Alrijne Hospital | |
Leiden, Zuid Holland, Netherlands, 2334 CK | |
Maastricht University Medical Center | |
Maastricht, Netherlands, 6229 ER |
Principal Investigator: | A Masclee, Prof., PhD., MD. | Maastricht University Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Maastricht University Medical Center |
ClinicalTrials.gov Identifier: | NCT02716285 |
Other Study ID Numbers: |
NL56000.068.16; METC162009 2015-005467-16 ( EudraCT Number ) |
First Posted: | March 23, 2016 Key Record Dates |
Last Update Posted: | November 2, 2018 |
Last Verified: | October 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Irritable Bowel Syndrome Abdominal pain Targeted Delivery Peppermint oil |
Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Syndrome Abdominal Pain Disease Pathologic Processes Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
Pain Neurologic Manifestations Signs and Symptoms, Digestive Peppermint oil Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Parasympatholytics |