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The Effect of CanChew® Cannabidiol (CBD) Containing Chewing Gum on Irritable Bowel Syndrome

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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
Sponsor:
Information provided by (Responsible Party):
Renger Witkamp, Wageningen University

Tracking Information
First Submitted Date  ICMJE December 14, 2016
First Posted Date  ICMJE December 26, 2016
Last Update Posted Date December 26, 2016
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of CanChew® Cannabidiol (CBD) Containing Chewing Gum on Irritable Bowel Syndrome
Official Title  ICMJE A Randomized, Double-blind, Cross-over Trial of the Effect of CanChew® Cannabidiol (CBD) Containing Chewing Gum on Patients With Irritable Bowel Syndrome
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE
  • Other: CBD chewing gum
    Other Name: CanChew®
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: Treatment A - Treatment B
    20 patients receive first 3 weeks treatment A and after a week wash-out 3 weeks treatment B
    Interventions:
    • Other: CBD chewing gum
    • Other: Placebo
  • Experimental: Treatment B - Treatment A
    20 patients receive first 3 weeks treatment B and after a week wash-out 3 weeks treatment A
    Interventions:
    • Other: CBD chewing gum
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 23, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 with a vas-score of 4 and higher per week
  • Signed informed consent

Exclusion Criteria:

  • Use SSRIs, tramadol or tramagetic
  • Have a history of intestinal surgery that might interfere with the outcome of the study
  • Female patients: currently pregnant or breast-feeding hope to become pregnant during the study, judged by the persons self.
  • Female who is not using the contraceptive pill.
  • Are an employee and students of the department of Human Nutrition at Wageningen UR, or employee at the MDL department of hospital Gelderse Vallei
  • Participate in another research study
  • Alcohol use (male more than 14 servings a week, female more than 7 servings a week)
  • Cannabis use is from 3 months before until the end of the study not allowed.
  • Hypersensitivity to one of the ingredients of the chewing gum
  • Drug use (CYP2C19 and CYP3A4) metabolised; medication will be evaluated for this by the principal and medical investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03003260
Other Study ID Numbers  ICMJE NL58588.081.16
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Renger Witkamp, Wageningen University
Study Sponsor  ICMJE Wageningen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Wageningen University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP