Investigate the effect of administration of CBD by means of CanChew® chewing gum versus a placebo on pain, IBS symptoms and perceived wellbeing in patients with IBS.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Investigate the effect of administration of CBD by means of CanChew® chewing
gum versus a placebo on pain, IBS symptoms and perceived wellbeing in patients
with IBS.
Secondary outcome
n.a.
Background summary
IBS is the most common functional gastrointestinal disorder with a prevalence
worldwide ranging from 9-23%. Complaints include abdominal discomfort or pain,
and altered bowel habits. Although the condition is not life-threatening, it
strongly impairs quality of life and up to now there is no cure. It is thought
that symptoms are caused by altered gut motility and secretion, visceral
hypersensitivity, and disturbances of brain-gut interactions. manipulation of
the CB1 and CB2 receptors by (endo)cannabinoids (endocannabinoids are
cannabinoids which are synthesized by the body itself) can alter gut motility
and gut secretions. Besides that, evidence suggests that cannabinoids can
decrease intestinal hypersensitivity as well. Therefore cannabidiol (CBD), is
of special interest as it does not show psychoactivity, while still having
therapeutic potential. Therefore we want to investigate if administration of
CBD by means of CanChew® chewing gum versus a placebo has an effect on pain,
IBS symptoms and perceived wellbeing in patients with IBS.
Study objective
Investigate the effect of administration of CBD by means of CanChew® chewing
gum versus a placebo on pain, IBS symptoms and perceived wellbeing in patients
with IBS.
Study design
A randomized, double-blind, cross-over trial of 8 weeks in total.
Intervention
Patients will, in this cross-over study, receive a maximum 6 chewing gums per
day, either containing cannabidiol, or a placebo chewing gum. Both
intervention periods will be 3 weeks with one week wash-out in between.
Participants can take the chewing gum when in pain, they will give this pain a
score and after 30 minutes of chewing they will give another score for the pain
to see what effect the chewing gum has on pain.
The participants will keep a diary for 8 weeks in total to monitor the pain
scores and changes in stools. Next to that they will fill in the IBS-QOL
questionnaire after week 1, week 5 and week 8.
Study burden and risks
CBD does not show psycho-activity, is generally considered non-toxic, and does
not induce changes in food intake, physiological parameters, and psychomotor
functions. However, there are indications that CBD may inhibit certain
cytochrome P450 enzymes, in particular CYP2C19 and CYP3A4. For this reason
patients will be excluded when they use medicatie that involves the same
enzymes. This will be evaluated by the principal investigator /
gastroenterologist. There have been no reports of clinical interactions with
medication in the literature as far as we know and chronic use of up to
1500mg/day are well tolerated in humans. Therefore no adverse effects are
expected and risks are null.
Stippeneng 4
Wageningen 6708 WE
NL
Stippeneng 4
Wageningen 6708 WE
NL
Listed location countries
Age
Inclusion criteria
* Male
* Female, only when using the contraceptive pill
* Adults, aged 18-65
* IBS, diagnosed according to the Rome III criteria
* More than 3 moments of pain a week with a VAS-score of 4 and higher
* Signed informed consent
Exclusion criteria
* Use of SSRIs, tramadol or tramagetic
* History of intestinal surgery that might interfere with the outcome of the study
* Female patients: currently pregnant, breast-feeding or intending to become pregnant during the study, judged by the persons self
* Female who is not using the contraceptive pill.
* Are an employee of the department of Human Nutrition at Wageningen UR, or employee of Ziekenhuis Gelderse Vallei
* Participate in another research study
* Alcohol use (male more than 14 servings a week, female more than 7 servings a week)
* Hypersensitivity to one of the ingredients of the chewing gum
* Cannabis use is from 3 months before untill the end of the study not allowed
* Drug use (CYP2C19 and CYP3A4) metabolised; medication will be evaluated for this by the principal and medical investigator.
Design
Recruitment
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 |
|---|---|
| CCMO | NL58588.081.16 |