A new formulation of peppermint oil for the treatment of Irritable Bowel Syndrome

Phase 1

• Conditions: Irritable Bowel Syndrome; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-005467-16-NL
• Lead Sponsor: Maastricht University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-09
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

1. Age between 18 and 75 years;
2. Diagnosed with Irritable Bowel Syndrome according to the Rome III criteria:
• Recurrent abdominal pain or discomfort, at least 3 days/month for the last 3 months;
• Symptom onset at least 6 months prior to diagnosis
• Associated with two or more of the following:
1. Improvement with defecation;
2. Onset associated with a change in frequency of stool;
3. Onset 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

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 clinical trial of medicinal product
• Study Design: Not specified