MedTrace Logo

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

NCT02716285 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2018-11-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • A Masclee, Prof., PhD., MD. · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-17
Primary Completion
2018-05-01
Completion
2018-10-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02716285 on ClinicalTrials.gov