NCT02828748

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

1.6 years

First QC Date

June 13, 2016

Last Update Submit

October 23, 2016

Conditions

Inflammatory Bowel Disease

Keywords

cannabinoidsinflammatory bowel disease

Outcome Measures

Primary Outcomes (5)

  • reduction of TNF alpha by more them 50% when cannabinoids appllied to culture

    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

    24 hours

  • reduction of IL-6 by more them 50% when cannabinoids applied to culture

    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

    24 hours

  • reduction of IL-8 by more them 50% when cannabinoids applied to culture

    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

    24 hours

  • reduction of IL-17 by more them 50% when cannabinoids applied to culture

    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

    24 hours

  • increase of IL-10 by more them 50% when cannabinoids applied to culture

    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

    24 hours

Study Arms (4)

active UC

EXPERIMENTAL

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

remission UC

EXPERIMENTAL

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

active CD

EXPERIMENTAL

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

remission CD

EXPERIMENTAL

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

Interventions

no intervention in patients treatment, only biopsy takenOTHER
active CDactive UCremission CDremission UC

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • established diagnosis if IBD informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastroenterology institute Meir Hospital

Kfar Saba, Israel

Location

Related Publications (2)

  • Browning TH, Trier JS. Organ culture of mucosal biopsies of human small intestine. J Clin Invest. 1969 Aug;48(8):1423-32. doi: 10.1172/JCI106108.

    PMID: 5796354RESULT

  • Naftali T, Bar-Lev Schleider L, Dotan I, Lansky EP, Sklerovsky Benjaminov F, Konikoff FM. Cannabis induces a clinical response in patients with Crohn's disease: a prospective placebo-controlled study. Clin Gastroenterol Hepatol. 2013 Oct;11(10):1276-1280.e1. doi: 10.1016/j.cgh.2013.04.034. Epub 2013 May 4.

    PMID: 23648372RESULT

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Fred Konnikoff, MD

    Meir Medical Center

    STUDY CHAIR

Central Study Contacts

Timna Naftali, MD

CONTACT

97297472743timna.naftali@clalit.org.il

Orly Hanin, Phd

CONTACT

97297471017orly.hanin@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 13, 2016

First Posted

July 12, 2016

Study Start

December 1, 2016

Primary Completion

July 1, 2018

Study Completion

September 1, 2018

Last Updated

October 25, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)