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The effect of CanChew®, cannabidiol (CBD) containing chewing gum on Irritable Bowel Syndrome

The effect of CanChew®, cannabidiol (CBD) containing chewing gum on Irritable Bowel Syndrome - The CANdidate study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43003
Enrollment
40
Registered
2016-12-08
Start date
2017-03-30
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

irritable bowel syndrome

Interventions

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 wa
Cannabidiol
Intestine

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
n.a.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)