Comparing a 182mg Colon-targeted-delivery Peppermint Oil Capsule (Tempocol-ColoPulse®) and a 182mg Enteric-coated Peppermint Oil Capsule (Tempocol®), a Pharmacokinetic Study
Condition: Irritable Bowel Syndrome; Abdominal Pain; Colonic Diseases; Visceral Pain
MeSH terms: Irritable Bowel Syndrome; Colonic Diseases; Abdominal Pain; Visceral Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a pilot study to compare the relative bioavailability between two peppermint oil
      formulations, namely a ileocolonic release peppermint oil and an small intestinal release
      peppermint oil (Tempocol®). This study is conducted as part of a future multicenter
      randomized controlled trial that will assess the therapeutic effect of the new peppermint oil
      formulation in IBS patients.
    

Detailed description: 
      Rationale: Peppermint oil has shown to be effective in the treatment of 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 plan to conduct a multicenter
      randomized controlled trial to investigate the possible beneficial effects of peppermint oil
      in IBS. To improve efficacy and to reduce side effects, the investigators aim to study the
      use of a new peppermint oil formulation that will slowly release the oil in the (ileo-)
      colonic region specifically. In order to demonstrate differences in pharmacokinetics, the
      subsidizing party, ZonMW, requested an additional pilot study (described in the present
      protocol) in which the investigators will investigate surrogate markers for local colon
      bioavailability, tolerability and side effects of the new ileocolonic release PO.

      Study design: a randomized, double blind, two-period, two-treatment crossover study with a
      wash out period of at least 14 days.

      Intervention: All study volunteers will receive a single dose of 182mg of both ileocolonic
      release peppermint oil and small intestinal release peppermint oil, each on a different test
      day.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: Subjects may be confronted with certain inconveniences and minor risks. They are
      required to visit the MUMC+ 5 times, once for the screening and two times per test day for
      various non-invasive measurements (questionnaires, blood pressure and heart-rate measurement,
      urine and fecal sampling, pregnancy test in women in fertile ages, general physical exam) as
      well as for minor invasive venous blood sampling, after which a small haematoma can occur.
      Total time investment is +/- 30 hours, subjects will not benefit from participation.
    

Intervention name(s): Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule); Menthae piperitae aetheroleum/peppermint oil (colon-targeted-delivery capsule)
Intervention type(s): Drug; Drug
Intervention description(s): Peppermint oil capsule available as an over the counter prescription drug on the Dutch market.; Peppermint oil capsule with a coating developed according to the ColoPulse® technology, ensuring a pulsatile and therefore slower release in a lower part of the intestinal tract compared to Tempocol, namely in the (ileo-)colonic region.
Other intervention name(s): Tempocol® (CBG-rvg number 109856); Tempocol-ColoPulse®
Intervention MeSH terms: Peppermint oil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Peppermint oil; Menthol; Volatile oil; Plant oil; Visceral pain; Abdominal pain; Irritable bowel syndrome (IBS); Colonic disease