NCT02716285

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irritable Bowel Syndrome
• Abdominal Pain
• Colonic Diseases, Functional

Interventions

Type	Name	Description
DRUG	Ileocolonic release peppermint oil	Peppermint oil, menthae piperitae aetheroleum
DRUG	Placebo	Placebo capsule, containing microcrystalline cellulose
DRUG	Small intestinal release peppermint oil	Peppermint oil, menthae piperitae aetheroleum

Timeline

• Start date: 2016-08-17
• Primary completion: 2018-05-01
• Completion: 2018-10-01
• First posted: 2016-03-23
• Last updated: 2018-11-02

Locations

4 sites across 1 country: Netherlands