Peppermint oil for the treatment of Irritable Bowel Syndrome: optimizing therapeutic strategies using targeted delivery

Phase 3

Completed

Conditions: abdominal pain
altered bowel habits
10017977

Registration Number: NL-OMON45856

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 234

Inclusion Criteria

1. Age between 18 and 75 years;
2. Diagnosed with Irritable Bowel Syndrome according to the Rome IV criteria:
* Recurrent abdominal pain or discomfort, at least 1 days/week for the last 3 months;
* Symptom onset at least 6 months prior to diagnosis
* Associated with two or more of the following:
1. Pain related with defecation;
2. Pain associated with a change in frequency of stool;
3. Pain associated with a change in form (appearance/consistency) of stool;
3. Based on the medical history and previous examination, no other causes for the abdominal complaints can be defined. Especially no history of:
a. Inflammatory Bowel Disease;
b. Celiac Disease;
c. 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.
4. Women in fertile age (<55 years old) must use contraception or be postmenopausal for at least two years.
5. Average worst abdominal pain score (on 11-point NRS) of > 3, during the two-week run-in period.

Exclusion Criteria

1. Insufficient fluency of the Dutch language;
2. Any previous use (also incidental use) of peppermint oil capsules in the last 3 months prior to inclusion;
3. 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);
a. The use of 1 antidepressant drug is allowed, providing dosing has been stable for > 6 weeks before enrollment;
b. The use of 1 proton pump inhibitors (PPI) is allowed, providing dosing has been stable > 6 weeks before enrollment;
4. Previous major abdominal surgery or radiotherapy interfering with gastrointestinal function:
a. Uncomplicated appendectomy, cholecystectomy and hysterectomy allowed unless within the past 6 months;
b. Other surgery upon judgment of the principle investigator;
5. History of liver disease, cholangitis, achlorhydria, gallstones or other diseases of the gallbladder/biliary system;
6. Pregnancy, lactation;
7. Using drugs of abuse;
8. Known allergic reaction to peppermint.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Abdominal pain response rate after 8 weeks of treatment.<br /><br>a. A responder is defined as a patient who experiences at least a 30 percent<br /><br>decrease in the weekly average of worst daily abdominal pain (measured daily,<br /><br>on an 11 point NRS) compared to baseline weekly average in at least 50 percent<br /><br>of the weeks in which the treatment in given.<br /><br><br /><br>2. Degree of relief response rate after 8 weeks of treatment.<br /><br>a. A responder is defined as a patient who experiences a weekly relief of 1 or<br /><br>2 (on a 7 point NRS) in at least 50 percent of the weeks in which treatment is<br /><br>given.</p><br>

Secondary Outcome Measures