Peppermint Oil for the Treatment of Irritable Bowel Syndrome: Optimizing Therapeutic Strategies Using Targeted Delivery (PERSUADE)

October 31, 2018 updated by: Maastricht University Medical Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6229 ER
        • Maastricht University Medical Center
    • Friesland
      • Leeuwarden, Friesland, Netherlands, 8934 AD
        • Medical Center Leeuwarden
    • Gelderland
      • Ede, Gelderland, Netherlands, 6716 RP
        • Gelderse Vallei Hospital
    • Zuid Holland
      • Leiden, Zuid Holland, Netherlands, 2334 CK
        • Alrijne Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks
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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global symptom improvement
Time Frame: 8 weeks
As determined by IBS-SSS (IBS symptom severity scale)
8 weeks
Abdominal Discomfort
Time Frame: 8 weeks
As determined by symptom diary
8 weeks
Bloating
Time Frame: 8 weeks
As determined by IBS-SSS (IBS - symptom severity scale)
8 weeks
Regurgitation
Time Frame: 8 weeks
As determined by symptom diary
8 weeks
Nausea
Time Frame: 8 weeks
As determined by symptom diary
8 weeks
Urgency
Time Frame: 8 weeks
As determined by symptom diary
8 weeks
Abdominal cramps
Time Frame: 8 weeks
As determined by symptom diary
8 weeks
Average stool frequency and consistency
Time Frame: 8 weeks
Measured by bristol stool chart
8 weeks
Indirect costs
Time Frame: 8 weeks, 3 and 6 months
Determined by Production Cost Questionnaire (PCQ) questionnaire
8 weeks, 3 and 6 months
Direct costs
Time Frame: 8 weeks, 3 and 6 months
Determined by Medical Cost Questionnaire (MCQ) questionnaire
8 weeks, 3 and 6 months
General Quality of Life
Time Frame: 8 weeks, 3 and 6 months
As determined by Euro-Qol-5D (EQ-5D)
8 weeks, 3 and 6 months
IBS related Quality of Life
Time Frame: 8 weeks, 3 and 6 months
As determined by IBS-Quality of life questionnaire (IBS-QoL)
8 weeks, 3 and 6 months
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)
8 weeks
Number and severity of side effects
Time Frame: 8 weeks
Determined by daily diary
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
3 and 6 months after discontinuation of treatment
Responder rates when missing are interpreted as "no effect"
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: A Masclee, Prof., PhD., MD., Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

March 8, 2016

First Submitted That Met QC Criteria

March 22, 2016

First Posted (Estimate)

March 23, 2016

Study Record Updates

Last Update Posted (Actual)

November 2, 2018

Last Update Submitted That Met QC Criteria

October 31, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL56000.068.16; METC162009
  • 2015-005467-16 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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