The Effect of CanChew® Cannabidiol (CBD) Containing Chewing Gum on Irritable Bowel Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03003260|
Recruitment Status : Unknown
Verified December 2016 by Renger Witkamp, Wageningen University.
Recruitment status was: Enrolling by invitation
First Posted : December 26, 2016
Last Update Posted : December 26, 2016
Rationale: 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 for IBS. It is assumed that IBS symptoms are related to a combination of altered gut motility and secretion, and visceral hypersensitivity. However, its primary cause still remains largely unknown. The endocannabinoid system, together with some functionally related receptors is among the biological targets considered promising for treatment. Modulation of the CB1 , CB2 and related receptors or enzymes of the endocannabinoid system in a broader sense by (endo) cannabinoids or (and) structurally related lipid mediators can influence motility, secretions and decrease hypersensitivity in the gut. Among the plant-derived cannabinoids or so called 'phytocannabinoids', cannabidiol (CBD) is of special interest as it has shown therapeutic potential in preclinical studies and a growing number of case-reports. CBD is a non-specific phytocannabinoid displaying a broad but weak receptor interaction profile. In contrast to the well-known THC from Cannabis sativa, CBD is not psychoactive and often also present in those Cannabis varieties that are not used for their psychoactive properties but for industrial (fibre) or food properties (oil, flour and seeds) instead. Based on preclinical studies and in vitro data we hypothesize that CBD might be able to relieve symptoms of IBS, including pain in patients with IBS. The chewing gum is to be taken 'on demand' and may have some additional perceived positive effects.
Objective: To investigate whether the use of a CBD-containing preparation in the form of CanChew® chewing gum can contribute to a reduction of IBS symptoms and an improvement of perceived wellbeing in patients with IBS.
Study design: A randomized, double-blind, cross-over trial of 8 weeks in total.
Study population: Adults, aged 18-65, diagnosed according to the ROME III criteria with Irritable Bowel Syndrome.
Intervention (if applicable): Patients will, in this cross-over study, receive a maximum 6 chewing gums per day, either containing 50 mg of cannabidiol per chewing gum in case of the CanChew chewing gum, or a placebo chewing gum. This first intervention period will last 3 weeks. Next, participants will undergo a one week wash-out and then switch intervention to either placebo or the CanChew chewing gum for another 3 weeks.
Main study parameters/endpoints: The main study parameter is a change in pain reduction perception experienced and measured by the patient using VAS-scales before and after taking the chewing gum, to be recorded in a diary. Next to this a patient is asked to provide one VAS score for each completed week. Furthermore, the adequate relief will be measured every day. At the end of each week patients will also be asked (from their diary) whether they noticed a change in stool frequency or (and) experienced any side-effects. For the disease-related quality of life the IBS-QOL will be used. This questionnaire will be filled out in week 1, 4, 5, and 8.
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Other: CBD chewing gum Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Cross-over Trial of the Effect of CanChew® Cannabidiol (CBD) Containing Chewing Gum on Patients With Irritable Bowel Syndrome|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||June 2017|
Experimental: Treatment A - Treatment B
20 patients receive first 3 weeks treatment A and after a week wash-out 3 weeks treatment B
Other: CBD chewing gum
Other Name: CanChew®
Experimental: Treatment B - Treatment A
20 patients receive first 3 weeks treatment B and after a week wash-out 3 weeks treatment A
Other: CBD chewing gum
Other Name: CanChew®
- Change of pain scores on the Visual analoge scale (VAS) between baseline and 3, 5 and 8 weeks of treatment [ Time Frame: Baseline, 3 weeks, 5 weeks and 8 weeks ]The main study parameter is a change in pain reduction perception experienced and measured by the patient using VAS-scales before and after taking the chewing gum, to be recorded in a diary
- Change of IBS-QOL baseline vs 3, 5 and 8 weeks of treatment [ Time Frame: Baseline, 3 weeks, 5 weeks and 8 weeks ]For the disease-related quality of life the IBS-QOL will be used
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003260
|Wageningen, Gelderland, Netherlands, 6700 EV|