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Irritable Bowel SyndromePhase 3PERSUADENCT02716285

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

A Phase 3 study testing Ileocolonic release peppermint oil and Small intestinal release peppermint oil in people with Irritable Bowel Syndrome and Abdominal Pain, run by Maastricht University Medical Center at 4 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Ileocolonic release peppermint oil and Small intestinal release peppermint oil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
190 participants
Where
4 sitesNetherlands
Study dates
17 Aug 2016to 1 Oct 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 75 years;
  • 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
Show all 12Show fewer
  • 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.

Who cannot join

  • 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);
  • 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;
  • Previous major abdominal surgery or radiotherapy interfering with gastrointestinal function:
Show all 12Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country.

Netherlands4 sites

  • Gelderse Vallei Hospital

    Ede, Gelderland, 6716 RP

  • Medical Center Leeuwarden

    Leeuwarden, Provincie Friesland, 8934 AD

  • Alrijne Hospital

    Leiden, South Holland, 2334 CK

  • Maastricht University Medical Center

    Maastricht, 6229 ER

Other trials in Netherlands

About this study

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.

Being tested
Ileocolonic release peppermint oil, Placebo, Small intestinal release peppermint oil
Keywords
Irritable Bowel Syndrome, Abdominal pain, Targeted Delivery, Peppermint oil
Medical subject headings
Irritable Bowel Syndrome, Abdominal Pain, Colonic Diseases, Functional

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ileocolonic release peppermint oilDrug

    Peppermint oil, menthae piperitae aetheroleum

  • PlaceboDrug

    Placebo capsule, containing microcrystalline cellulose

  • Small intestinal release peppermint oilDrug

    Also called Tempocol

    Peppermint oil, menthae piperitae aetheroleum

Study groups in NCT02716285
Study groupRoleWhat they receive
Ileocolonic release peppermint oilExperimentalColon-targeted-delivery capsule containing 182mg of Peppermint Oil, to be taken orally, 3 times daily for 8 weeks (first week, dosing will be titred).
Receives: Drug: Ileocolonic release peppermint oil
Small intestinal release peppermint oil (Tempocol®)ExperimentalEnteric-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).
Receives: Drug: Small intestinal release peppermint oil
PlaceboPlacebo comparatorCapsule containing microcrystalline cellulose, to be taken orally, 3 times daily for 8 weeks (first week, dosing will be titred).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 weeks

  2. 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.

    Measured: 8 weeks

Secondary outcomes (16)

  1. Global symptom improvement

    As determined by IBS-SSS (IBS symptom severity scale)

    Measured: 8 weeks

  2. Abdominal Discomfort

    As determined by symptom diary

    Measured: 8 weeks

  3. Bloating

    As determined by IBS-SSS (IBS - symptom severity scale)

    Measured: 8 weeks

  4. Regurgitation

    As determined by symptom diary

    Measured: 8 weeks

  5. Nausea

    As determined by symptom diary

    Measured: 8 weeks

  6. Urgency

    As determined by symptom diary

    Measured: 8 weeks

  7. Abdominal cramps

    As determined by symptom diary

    Measured: 8 weeks

  8. Average stool frequency and consistency

    Measured by bristol stool chart

    Measured: 8 weeks

  9. Indirect costs

    Determined by Production Cost Questionnaire (PCQ) questionnaire

    Measured: 8 weeks, 3 and 6 months

  10. Direct costs

    Determined by Medical Cost Questionnaire (MCQ) questionnaire

    Measured: 8 weeks, 3 and 6 months

  11. General Quality of Life

    As determined by Euro-Qol-5D (EQ-5D)

    Measured: 8 weeks, 3 and 6 months

  12. IBS related Quality of Life

    As determined by IBS-Quality of life questionnaire (IBS-QoL)

    Measured: 8 weeks, 3 and 6 months

  13. Use of Over the counter medication and rescue medication

    Number of drugs taken as rescue medication (This is not an intervention)

    Measured: 8 weeks

  14. Number and severity of side effects

    Determined by daily diary

    Measured: 8 weeks

  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);

    Measured: 3 and 6 months after discontinuation of treatment

  16. Responder rates when missing are interpreted as "no effect"

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2016 (estimated)
  2. Study start17 Aug 2016
  3. Primary completion1 May 2018
  4. Study completion1 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02716285
Sponsor's protocol ID
NL56000.068.16; METC162009
Other IDs
2015-005467-16, 2015
Acronym
PERSUADE
Status last verified
Oct 2018
First submitted
8 Mar 2016
Last updated
2 Nov 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Schellekens RC, Stellaard F, Olsder GG, Woerdenbag HJ, Frijlink HW, Kosterink JG. Oral ileocolonic drug delivery by the colopulse-system: a bioavailability study in healthy volunteers. J Control Release. 2010 Sep 15;146(3):334-40. doi: 10.1016/j.jconrel.2010.05.028. Epub 2010 May 31.

    PubMed 20621586

  • Maurer JM, Schellekens RC, van Rieke HM, Stellaard F, Wutzke KD, Buurman DJ, Dijkstra G, Woerdenbag HJ, Frijlink HW, Kosterink JG. ColoPulse tablets perform comparably in healthy volunteers and Crohn's patients and show no influence of food and time of food intake on bioavailability. J Control Release. 2013 Dec 28;172(3):618-24. doi: 10.1016/j.jconrel.2013.09.021. Epub 2013 Oct 2.

    PubMed 24096020

  • Khanna R, MacDonald JK, Levesque BG. Peppermint oil for the treatment of irritable bowel syndrome: a systematic review and meta-analysis. J Clin Gastroenterol. 2014 Jul;48(6):505-12. doi: 10.1097/MCG.0b013e3182a88357.

    PubMed 24100754

  • Enck P, Junne F, Klosterhalfen S, Zipfel S, Martens U. Therapy options in irritable bowel syndrome. Eur J Gastroenterol Hepatol. 2010 Dec;22(12):1402-11. doi: 10.1097/MEG.0b013e3283405a17.

    PubMed 21389791

  • Ford AC, Talley NJ, Spiegel BM, Foxx-Orenstein AE, Schiller L, Quigley EM, Moayyedi P. Effect of fibre, antispasmodics, and peppermint oil in the treatment of irritable bowel syndrome: systematic review and meta-analysis. BMJ. 2008 Nov 13;337:a2313. doi: 10.1136/bmj.a2313.

    PubMed 19008265

  • Weerts ZZRM, Keszthelyi D, Vork L, Aendekerk NCP, Frijlink HW, Brouwers JRBJ, Neef C, Jonkers DMAE, Masclee AAM. A Novel Ileocolonic Release Peppermint Oil Capsule for Treatment of Irritable Bowel Syndrome: A Phase I Study in Healthy Volunteers. Adv Ther. 2018 Nov;35(11):1965-1978. doi: 10.1007/s12325-018-0802-1. Epub 2018 Oct 4.

    PubMed 30284674

  • Weerts ZZRM, Essers BAB, Jonkers DMAE, Willems JIA, Janssen DJPA, Witteman BJM, Clemens CHM, Westendorp A, Masclee AAM, Keszthelyi D. A trial-based economic evaluation of peppermint oil for the treatment of irritable bowel syndrome. United European Gastroenterol J. 2021 Nov;9(9):997-1006. doi: 10.1002/ueg2.12134. Epub 2021 Sep 1.

    PubMed 34468079

  • Weerts ZZRM, Masclee AAM, Witteman BJM, Clemens CHM, Winkens B, Brouwers JRBJ, Frijlink HW, Muris JWM, De Wit NJ, Essers BAB, Tack J, Snijkers JTW, Bours AMH, de Ruiter-van der Ploeg AS, Jonkers DMAE, Keszthelyi D. Efficacy and Safety of Peppermint Oil in a Randomized, Double-Blind Trial of Patients With Irritable Bowel Syndrome. Gastroenterology. 2020 Jan;158(1):123-136. doi: 10.1053/j.gastro.2019.08.026. Epub 2019 Aug 27.

    PubMed 31470006

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ileocolonic release peppermint oil and Small intestinal release peppermint oil in people with Irritable Bowel Syndrome and Abdominal Pain, run by Maastricht University Medical Center at 4 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Abdominal pain response rate after 8 weeks of treatment (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02716285, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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