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Cytokine Production of Colonic Tissue From IBD Patients

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: NCT02828748
Recruitment Status : Unknown
Verified October 2016 by NAFTALI TIMNA, Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 12, 2016
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
NAFTALI TIMNA, Meir Medical Center

Brief Summary:

Chronic intestinal inflammation characterizes inflammatory bowel diseases (IBD), which consist mainly of Crohn's disease and ulcerative colitis. The exact etiology is unknown for both diseases and therapeutic attempts aimed at down-regulating intestinal inflammation use both mediator-specific and nonspecific immune suppression. These attempts cause considerable side effects. Also, IBD patients are different in their genetic background and pathology. It was previously shown that products based on marijuana (Cannabis sativa) produce beneficial effects for patients with IBD, and medical cannabis-based products were formerly proven to have anti-inflammatory activity in laboratory experiments and in clinical tests. However, it is unknown how C. sativa-based medical products exert their effect in IBD and additional research and development should be done. One issue to be resolved in the process of medicalization of C. sativa is the base for the differences in patient response to different C. sativa lines, in order to fine-tune C. sativa -based treatment to IBD patients.

For this aim of fine-tuning C. sativa -based treatment to IBD patients, we characterized the chemical composition of different C. sativa lines and their anti-inflammatory activities on colon cells lines. Extracts of C. sativa lines were prepared using various methods and cannabinoids and terpenoids profile was determined by chemical analysis. We found that different compounds have different effects on inflamed colon cell lines, leading to changes in interleukin secretion, inflammation markers and gene expression in the treated colon cells. In addition, we have developed a unique system relevant for personalized medicine in IBD. This system allows a patient-specific determination of the effect of C. sativa -based treatment. Following, clinical tests will be conducted aiming to develop cannabis-based products from different C. sativa lines, with anti-inflammatory activity that is effective and optimized for the different IBD patients.


Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Other: no intervention in patients treatment, only biopsy taken Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Cannabinoids on Cytokine Production of Colonic Tissue From IBD Patients
Study Start Date : December 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : September 2018

Arm Intervention/treatment
Experimental: active UC
patients with clinically active ulcerative colitis undergoing colonoscopy not for study purpose, biopsy will be taken from inflamed and normal mucosa and treated with either cannabinoids or will be used as a control
Other: no intervention in patients treatment, only biopsy taken
Experimental: remission UC
patients with clinically non active ulcerative colitis undergoing colonoscopy not for study purpose, biopsy will be taken from inflamed and normal mucosa and treated with either cannabinoids or will be used as a control
Other: no intervention in patients treatment, only biopsy taken
Experimental: active CD
patients with clinically active crohns disease undergoing colonoscopy not for study purpose, biopsy will be taken from inflamed and normal mucosa and treated with either cannabinoids or will be used as a control
Other: no intervention in patients treatment, only biopsy taken
Experimental: remission CD
patients with clinically non active crohns disease undergoing colonoscopy not for study purpose, biopsy will be taken from inflamed and normal mucosa and treated with either cannabinoids or will be used as a control
Other: no intervention in patients treatment, only biopsy taken



Primary Outcome Measures :
  1. reduction of TNF alpha by more them 50% when cannabinoids appllied to culture [ Time Frame: 24 hours ]
    different extracts of cannabis sativa will be applied to culture of biopsy and the cytokins TNF alpha, will be measured in the supernatant of the treated biopsies and compared to controls

  2. reduction of IL-6 by more them 50% when cannabinoids applied to culture [ Time Frame: 24 hours ]
    different extracts of cannabis sativa will be applied to culture of biopsy and the cytokin IL-6, will be measured in pg/ml in the supernatant of the treated biopsies and compared to controls

  3. reduction of IL-8 by more them 50% when cannabinoids applied to culture [ Time Frame: 24 hours ]
    different extracts of cannabis sativa will be applied to culture of biopsy and the cytokine IL-8, will be measured in pg/ml in the supernatant of the treated biopsies and compared to controls

  4. reduction of IL-17 by more them 50% when cannabinoids applied to culture [ Time Frame: 24 hours ]
    different extracts of cannabis sativa will be applied to culture of biopsy and the cytokine IL-17, will be measured in pg/ml in the supernatant of the treated biopsies and compared to controls

  5. increase of IL-10 by more them 50% when cannabinoids applied to culture [ Time Frame: 24 hours ]
    different extracts of cannabis sativa will be applied to culture of biopsy and the cytokine IL-10, will be measured in pg/ml in the supernatant of the treated biopsies and compared to controls



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • established diagnosis if IBD informed consent

Exclusion Criteria:

  • contra indication for a biopsy, such as a risk of hemorrhage

Information from the National Library of Medicine

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): NCT02828748


Contacts
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Contact: Timna Naftali, MD 97297472743 timna.naftali@clalit.org.il
Contact: Orly Hanin, Phd 97297471017 orly.hanin@clalit.org.il

Locations
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Israel
Gastroenterology institute Meir Hospital
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
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Study Chair: Fred Konnikoff, MD Meir Medical Center
Publications of Results:
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Responsible Party: NAFTALI TIMNA, MD, Meir Medical Center
ClinicalTrials.gov Identifier: NCT02828748    
Other Study ID Numbers: 0094 MMC
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by NAFTALI TIMNA, Meir Medical Center:
cannabinoids
inflammatory bowel disease
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis