1. To assess the efficacy and safety profile of treatment of IBS symptoms with peppermint oil compared to placebo. Thereby superiority of peppermint oil can be scientifically supported, leading to increased recognition of this therapy in IBS.2. To…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Abdominal pain response rate after 8 weeks of treatment.
a. 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.
2. Degree of relief response rate after 8 weeks of treatment.
a. 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.
Secondary outcome
Global symptom improvement, abdominal discomfort, bloating, regurgitation,
nausea, urgency, abdominal cramps (as determined by symptom diary and Irritable
Bowel Syndrome Symptom Severity Scale (IBS-SSS), average stool frequency and
consistency (measured by the Bristol Stool Form Scale) at baseline and after
treatment (number of complete spontaneous bowel movements (CSBMs) for IBS-C,
more lumpy stools in case of IBS-D), cost-utility (as determined by
calculations with EQ-5D, direct costs MCP, indirect costs PCQ and social
tariff), quality of life (as determined by the EQ-5D and IBS-QoL), use of OTC
and rescue medication, number and severity of side effects, responder rates
following discontinuation of treatment at 4 and 6 months, different thresholds
for the responder analysis of abdominal pain (e.g. 40 and 50 percent
improvement). Worst-case-analysis: imputing a non-response day for each day on
which the electronic diary entry was missing (due to non-reporting of the
patient).
Background summary
Peppermint oil has shown to be effective in the treatment of IBS symptoms in
several meta-analyses. However, the level of evidence is moderate and
peppermint oil remains relatively under-used in IBS. Therefore, we plan to
conduct a multicenter randomized controlled trial to investigate the effects of
an eight-week peppermint oil treatment in IBS patients according to current
EMA/FDA guidelines. To improve efficacy and to reduce side effects, we 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.
Study objective
1. To assess the efficacy and safety profile of treatment of IBS symptoms with
peppermint oil compared to placebo. Thereby superiority of peppermint oil can
be scientifically supported, leading to increased recognition of this therapy
in IBS.
2. To ascertain whether treatment of IBS symptoms with colon-targeted-delivery
peppermint oil results in a greater reduction of IBS symptoms and reduction of
side effects, compared to enteric-coated capsules delivering the oil in the
small intestine.
Study design
a randomized, double blind, placebo-controlled clinical trial with three
parallel study arms.
Intervention
group A will receive 8 weeks of daily treatment with enteric-coated peppermint
oil capsules (Tempocol®), group B will receive 8 weeks of daily treatment with
colon-targeted-delivery peppermint oil capsules (Tempocol-ColoPulse®), group C
will receive 8 weeks of daily treatment with placebo capsules.
Study burden and risks
Subjects may be confronted with certain inconveniences and minor risks. Study
participants have to visit the hospital 4 times, including the first visit in
which eligible subjects will be screened before participation. The screening
will take up to 1 hour and will consist of a simple questionnaire, a general
physical exam performed by the physician-investigator and a standard pregnancy
test (in women of fertile age, <55 year only). If deemed suitable by the
investigator, subjects will enter the run-in period. During this period,
patients are asked to report their daily stool and symptom scores to an
electronic diary. If after the run-in period, patients meet the in- and
exclusion criteria, they will enter the treatment period. If randomized to
peppermint oil treatment, the subject may feel relief of IBS symptoms. If
randomized to placebo, the subject may experience minor burden due to not
receiving treatment (although dietary and lifestyle advice continue). Side
effects of peppermint oil include heartburn, esophageal reflux, a burning anal
sensation and a headache. During the treatment period, daily symptom and stool
scores have to be reported. Moreover, several questionnaires have to be
competed at several time-points, taking several hours in total.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-005467-16-NL |
| ClinicalTrials.gov | NCT02716285 |
| CCMO | NL56000.068.16 |