<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03003260</url>
  </required_header>
  <id_info>
    <org_study_id>NL58588.081.16</org_study_id>
    <nct_id>NCT03003260</nct_id>
  </id_info>
  <brief_title>The Effect of CanChew® Cannabidiol (CBD) Containing Chewing Gum on Irritable Bowel Syndrome</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wageningen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wageningen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale: IBS is the most common functional gastrointestinal disorder with a prevalence&#xD;
      worldwide ranging from 9-23%. Complaints include abdominal discomfort or pain and altered&#xD;
      bowel habits. Although the condition is not life-threatening, it strongly impairs quality of&#xD;
      life and up to now there is no cure for IBS. It is assumed that IBS symptoms are related to a&#xD;
      combination of altered gut motility and secretion, and visceral hypersensitivity. However,&#xD;
      its primary cause still remains largely unknown. The endocannabinoid system, together with&#xD;
      some functionally related receptors is among the biological targets considered promising for&#xD;
      treatment. Modulation of the CB1 , CB2 and related receptors or enzymes of the&#xD;
      endocannabinoid system in a broader sense by (endo) cannabinoids or (and) structurally&#xD;
      related lipid mediators can influence motility, secretions and decrease hypersensitivity in&#xD;
      the gut. Among the plant-derived cannabinoids or so called 'phytocannabinoids', cannabidiol&#xD;
      (CBD) is of special interest as it has shown therapeutic potential in preclinical studies and&#xD;
      a growing number of case-reports. CBD is a non-specific phytocannabinoid displaying a broad&#xD;
      but weak receptor interaction profile. In contrast to the well-known THC from Cannabis&#xD;
      sativa, CBD is not psychoactive and often also present in those Cannabis varieties that are&#xD;
      not used for their psychoactive properties but for industrial (fibre) or food properties&#xD;
      (oil, flour and seeds) instead. Based on preclinical studies and in vitro data we hypothesize&#xD;
      that CBD might be able to relieve symptoms of IBS, including pain in patients with IBS. The&#xD;
      chewing gum is to be taken 'on demand' and may have some additional perceived positive&#xD;
      effects.&#xD;
&#xD;
      Objective: To investigate whether the use of a CBD-containing preparation in the form of&#xD;
      CanChew® chewing gum can contribute to a reduction of IBS symptoms and an improvement of&#xD;
      perceived wellbeing in patients with IBS.&#xD;
&#xD;
      Study design: A randomized, double-blind, cross-over trial of 8 weeks in total.&#xD;
&#xD;
      Study population: Adults, aged 18-65, diagnosed according to the ROME III criteria with&#xD;
      Irritable Bowel Syndrome.&#xD;
&#xD;
      Intervention (if applicable): Patients will, in this cross-over study, receive a maximum 6&#xD;
      chewing gums per day, either containing 50 mg of cannabidiol per chewing gum in case of the&#xD;
      CanChew chewing gum, or a placebo chewing gum. This first intervention period will last 3&#xD;
      weeks. Next, participants will undergo a one week wash-out and then switch intervention to&#xD;
      either placebo or the CanChew chewing gum for another 3 weeks.&#xD;
&#xD;
      Main study parameters/endpoints: The main study parameter is a change in pain reduction&#xD;
      perception experienced and measured by the patient using VAS-scales before and after taking&#xD;
      the chewing gum, to be recorded in a diary. Next to this a patient is asked to provide one&#xD;
      VAS score for each completed week. Furthermore, the adequate relief will be measured every&#xD;
      day. At the end of each week patients will also be asked (from their diary) whether they&#xD;
      noticed a change in stool frequency or (and) experienced any side-effects. For the&#xD;
      disease-related quality of life the IBS-QOL will be used. This questionnaire will be filled&#xD;
      out in week 1, 4, 5, and 8.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of pain scores on the Visual analoge scale (VAS) between baseline and 3, 5 and 8 weeks of treatment</measure>
    <time_frame>Baseline, 3 weeks, 5 weeks and 8 weeks</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of IBS-QOL baseline vs 3, 5 and 8 weeks of treatment</measure>
    <time_frame>Baseline, 3 weeks, 5 weeks and 8 weeks</time_frame>
    <description>For the disease-related quality of life the IBS-QOL will be used</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>Treatment A - Treatment B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 patients receive first 3 weeks treatment A and after a week wash-out 3 weeks treatment B</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B - Treatment A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 patients receive first 3 weeks treatment B and after a week wash-out 3 weeks treatment A</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CBD chewing gum</intervention_name>
    <arm_group_label>Treatment A - Treatment B</arm_group_label>
    <arm_group_label>Treatment B - Treatment A</arm_group_label>
    <other_name>CanChew®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Treatment A - Treatment B</arm_group_label>
    <arm_group_label>Treatment B - Treatment A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Female, only when using the contraceptive pill&#xD;
&#xD;
          -  Adults, aged 18-65&#xD;
&#xD;
          -  IBS, diagnosed according to the Rome III criteria&#xD;
&#xD;
          -  More than 3 moments of pain with a vas-score of 4 and higher per week&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use SSRIs, tramadol or tramagetic&#xD;
&#xD;
          -  Have a history of intestinal surgery that might interfere with the outcome of the&#xD;
             study&#xD;
&#xD;
          -  Female patients: currently pregnant or breast-feeding hope to become pregnant during&#xD;
             the study, judged by the persons self.&#xD;
&#xD;
          -  Female who is not using the contraceptive pill.&#xD;
&#xD;
          -  Are an employee and students of the department of Human Nutrition at Wageningen UR, or&#xD;
             employee at the MDL department of hospital Gelderse Vallei&#xD;
&#xD;
          -  Participate in another research study&#xD;
&#xD;
          -  Alcohol use (male more than 14 servings a week, female more than 7 servings a week)&#xD;
&#xD;
          -  Cannabis use is from 3 months before until the end of the study not allowed.&#xD;
&#xD;
          -  Hypersensitivity to one of the ingredients of the chewing gum&#xD;
&#xD;
          -  Drug use (CYP2C19 and CYP3A4) metabolised; medication will be evaluated for this by&#xD;
             the principal and medical investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Wageningen University</name>
      <address>
        <city>Wageningen</city>
        <state>Gelderland</state>
        <zip>6700 EV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>December 23, 2016</last_update_submitted>
  <last_update_submitted_qc>December 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wageningen University</investigator_affiliation>
    <investigator_full_name>Renger Witkamp</investigator_full_name>
    <investigator_title>Head of Nutrition and Pharmacology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03003260
org study id: NL58588.081.16
nct id: NCT03003260
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: 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
description: 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
measure: Change of IBS-QOL baseline vs 3, 5 and 8 weeks of treatment
time frame: Baseline, 3 weeks, 5 weeks and 8 weeks
description: For the disease-related quality of life the IBS-QOL will be used
arm group label: Treatment A - Treatment B
arm group type: Experimental
description: 20 patients receive first 3 weeks treatment A and after a week wash-out 3 weeks treatment B
arm group label: Treatment B - Treatment A
arm group type: Experimental
description: 20 patients receive first 3 weeks treatment B and after a week wash-out 3 weeks treatment A
intervention type: Other
intervention name: CBD chewing gum
arm group label: Treatment A - Treatment B
arm group label: Treatment B - Treatment A
other name: CanChew®
intervention type: Other
intervention name: Placebo
arm group label: Treatment A - Treatment B
arm group label: Treatment B - Treatment A
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Wageningen University
investigator full name: Renger Witkamp
investigator title: Head of Nutrition and Pharmacology
mesh term: Irritable Bowel Syndrome
mesh term: Syndrome
sharing ipd: No