The Effect of Cannabinoids on Cytokine Production of Colonic Tissue From IBD Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- reduction of TNF alpha by more them 50% when cannabinoids appllied to culture
研究概览
简要总结
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.
详细描述
Title of the project:
Efficacy of cannabinoids in the treatment of inflammatory bowel disease
Question to be investigated:
The marijuana plant, Cannabis sativa has been used as a medicinal treatment for a variety of diseases. Cannabinoids have been reported to alleviate neurological conditions including MS-related symptoms such as spasticity, pain, tremor and bladder dysfunction . Other neurological conditions, such as chronic intractable pain, dystonic movement disorders, and Tourette's Syndrome were also reported to be alleviated by cannabis use . Cannabis has been used to treat anorexia in AIDS and cancer patients. In gastroenterology, cannabis has been used to treat anorexia, emesis, abdominal pain, gastroenteritis, diarrhea, intestinal inflammation, and diabetic gastroparesis .
The cannabis plant contains over 60 different compounds which are collectively referred to as cannabinoids . Of these, the two compounds delta 9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) seem to be the most active.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •established diagnosis if IBD informed consent
排除标准
- •contra indication for a biopsy, such as a risk of hemorrhage
结局指标
主要结局
reduction of TNF alpha by more them 50% when cannabinoids appllied to culture
时间窗: 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
reduction of IL-6 by more them 50% when cannabinoids applied to culture
时间窗: 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
reduction of IL-17 by more them 50% when cannabinoids applied to culture
时间窗: 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
reduction of IL-8 by more them 50% when cannabinoids applied to culture
时间窗: 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
increase of IL-10 by more them 50% when cannabinoids applied to culture
时间窗: 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
次要结局
未报告次要终点