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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
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Abdominal Pain Colonic Diseases, Functional Drug: Ileocolonic release peppermint oil Drug: Placebo Drug: Small intestinal release peppermint oil Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

Arms and Interventions
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Arm Intervention/treatment
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).
 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).
 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).
 Drug: Placebo
Placebo capsule, containing microcrystalline cellulose


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Global symptom improvement [ Time Frame: 8 weeks ]
    As determined by IBS-SSS (IBS symptom severity scale)

  2. Abdominal Discomfort [ Time Frame: 8 weeks ]
    As determined by symptom diary

  3. Bloating [ Time Frame: 8 weeks ]
    As determined by IBS-SSS (IBS - symptom severity scale)

  4. Regurgitation [ Time Frame: 8 weeks ]
    As determined by symptom diary

  5. Nausea [ Time Frame: 8 weeks ]
    As determined by symptom diary

  6. Urgency [ Time Frame: 8 weeks ]
    As determined by symptom diary

  7. Abdominal cramps [ Time Frame: 8 weeks ]
    As determined by symptom diary

  8. Average stool frequency and consistency [ Time Frame: 8 weeks ]
    Measured by bristol stool chart

  9. Indirect costs [ Time Frame: 8 weeks, 3 and 6 months ]
    Determined by Production Cost Questionnaire (PCQ) questionnaire

  10. Direct costs [ Time Frame: 8 weeks, 3 and 6 months ]
    Determined by Medical Cost Questionnaire (MCQ) questionnaire

  11. General Quality of Life [ Time Frame: 8 weeks, 3 and 6 months ]
    As determined by Euro-Qol-5D (EQ-5D)

  12. IBS related Quality of Life [ Time Frame: 8 weeks, 3 and 6 months ]
    As determined by IBS-Quality of life questionnaire (IBS-QoL)

  13. 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)

  14. Number and severity of side effects [ Time Frame: 8 weeks ]
    Determined by daily diary

  15. 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 ]
  16. Responder rates when missing are interpreted as "no effect" [ Time Frame: 8 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  1. Age between 18 and 75 years;

  2. 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:

    1. Pain related to defecation;
    2. Pain associated with a change in frequency of stool;
    3. Pain 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:

    1. Inflammatory Bowel Disease;
    2. Celiac Disease;
    3. 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.

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 (the use of peppermint tea, menthol candy etc. is allowed);

  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). This use should be halted at least 1 week before enrollment into the run-in period;

    1. The use of 1 antidepressant drug is allowed, providing dosing has been stable for > 6 weeks before enrollment;
    2. The use of 1 proton pump inhibitor (PPI) is allowed, providing dosing has been stable > 6 weeks before enrollment;

  4. Previous major abdominal surgery or radiotherapy interfering with gastrointestinal function:

    1. Uncomplicated appendectomy, cholecystectomy and hysterectomy allowed unless within the past 6 months;
    2. 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Principal Investigator: A Masclee, Prof., PhD., MD. Maastricht University Medical Center
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Maastricht University Medical Center:
Irritable Bowel Syndrome
Abdominal pain
Targeted Delivery
Peppermint oil
Additional relevant MeSH terms:
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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