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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Maastricht University Medical Center

Current Primary Outcome:

• 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.
• 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

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

Original Secondary Outcome:

• Global symptom improvement [ Time Frame: 8 weeks ]
  As determined by IBS-SSS (IBS symptom severity scale)
• Abdominal Discomfort [ Time Frame: 8 weeks ]
  As determined by symptom diary
• Bloating [ Time Frame: 8 weeks ]
  As determined by IBS-SSS (IBS - symptom severity scale)
• Regurgitation [ Time Frame: 8 weeks ]
  As determined by symptom diary
• Nausea [ Time Frame: 8 weeks ]
  As determined by symptom diary
• Urgency [ Time Frame: 8 weeks ]
  As determined by symptom diary
• Abdominal cramps [ Time Frame: 8 weeks ]
  As determined by symptom diary
• Average stool frequency and consistency [ Time Frame: 8 weeks ]
  Measured by bristol stool chart
• Indirect costs [ Time Frame: 8 weeks, 3 and 6 months ]
  Determined by PCQ questionnaire
• Direct costs [ Time Frame: 8 weeks, 3 and 6 months ]
  Determined by MCP questionnaire
• General Quality of Life [ Time Frame: 8 weeks, 3 and 6 months ]
  As determined by EQ-5D
• IBS related Quality of Life [ Time Frame: 8 weeks, 3 and 6 months ]
  As determined by IBS-QoL
• 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)
• Number and severity of side effects [ Time Frame: 8 weeks ]
  Determined by daily diary
• 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 ]
• Responder rates when missing are interpreted as "no effect" [ Time Frame: 8 weeks ]

Information By: Maastricht University Medical Center

Dates:
Date Received: March 8, 2016
Date Started: August 17, 2016
Date Completion: June 25, 2018
Last Updated: May 16, 2017
Last Verified: May 2017