Inflammatory Bowel Diseases (IBD) Cannabis Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Determine the clinical response rates using SCCAI (Simple Clinical Colitis Activity Index) in patients with Ulcerative Colitis receiving cannabis at week 4
研究概览
简要总结
The inflammatory bowel diseases (IBDs), ulcerative colitis (UC) and Crohn's disease (CD), are characterized by lifelong relapsing-remitting gastrointestinal inflammation, with symptoms of abdominal pain, diarrhea, and rectal bleeding during active disease. Medical therapy reduces intestinal inflammation and ameliorates symptoms. Medical cannabis has recently been added to the arsenal of symptom-reducing measures in IBD. Though the efficacy of THC and CBD have been established as the two most dominant ingredients of cannabis, the rest of the plant phytochemicals are unknown, and effects on patients are not yet determined.
详细描述
Hypothesis (es) and Aims:
Prospectively follow IBD patients receiving medical cannabis as treatment of their disease (group 1) in comparison to the following control groups:
- Healthy patients who do not use cannabis; 3) IBD patients who experience pain and do not use cannabis; 4) IBD patients who do not experience pain and do not use cannabis; 5) IBD patients previously prescribed cannabis and were identified to have positive effect on their disease
• Specific aims: a prospective trial to determine whether cannabis can induce remission in patients with IBD.
- To identify treatment regimens associated with treatment success in IBD patients.
- To identify treatment regimens associated with treatment side effects in IBD patients.
- To analyze the optimal drug level for disease management in various IBD patient types.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients (male and female, age 18-80 years) diagnosed with Crohn's disease (CD), ulcerative colitis (UC) or pouchitis, and healthy volunteers.
- •All patients will sign an informed consent form. IBD patients who are recruited to group 3 will be included if they report mild-severe abdominal pain in clinical questioning of clinical activity (Harvey-Bradshaw index).
- •Healthy participants recruited to group 2 will be healthy volunteers with no prior/current use of medical cannabis
排除标准
- •Inability to sign an informed consent and complete the study protocol
- •Unstable or uncontrolled medical disorder, or severe systemic disease (other than IBD)
- •Participating in clinical interventional trial unrelated to cannabis derived preparations
- •Ileostomy/ colostomy
- •Pregnancy or intent to become pregnant in the next 6 month or breast feeding during the study
研究组 & 干预措施
• Group 1 (study group)
IBD patients prescribed cannabis as treatment of their bowel disease.
干预措施: Medical Cannabis (Drug)
结局指标
主要结局
Determine the clinical response rates using SCCAI (Simple Clinical Colitis Activity Index) in patients with Ulcerative Colitis receiving cannabis at week 4
时间窗: week 4
Disease clinical response will be measured as the change in SCCAI scores from baseline to week 4. A clinical response is defined as reduction of at list 30% in SCCAI score, ∆SCCAI\>30% for Ulcerative Colitis SCCAI (Simple Clinical Colitis Activity Index) is used to assess the severity of symptoms in people who suffer from ulcerative colitis. Score range from 0 to 19 points 0\<SCCAI\<19. Higher score means higher disease activity and severity.
Determine the clinical response rates using SCCAI (Simple Clinical Colitis Activity Index) in patients with Ulcerative Colitis receiving cannabis at week 24
时间窗: Week 24
Disease clinical response will be measured as the change in SCCAI scores from baseline to week 24. A clinical response is defined as reduction of at list 30% in SCCAI score, ∆SCCAI\>30% for Ulcerative Colitis SCCAI (Simple Clinical Colitis Activity Index) is used to assess the severity of symptoms in people who suffer from ulcerative colitis. Score range from 0 to 19 points 0\<SCCAI\<19. Higher score means higher disease activity and severity.
Determine patients clinical response rates using Harvey-Bradshaw Index (HBI) in Crohn's disease patients receiving cannabis at week 24
时间窗: Week 24
Disease clinical response will be measured as the change in HBI scores from baseline to week 24. A clinical response is defined as reduction of at least 3 points in HBI score, ∆HBI\>3 in patients with baseline HBI\>7. Harvey-Bradshaw Index (HBI) is a tool for assessing the degree of illness (activity) in patient's with Crohn's disease. Higher score means higher disease activity and severity. A drop \> 3 is considered a clinical response.
Determine patients clinical response rates using Harvey-Bradshaw Index (HBI) in Crohn's disease patients receiving cannabis at week 4
时间窗: week 4
Disease clinical response will be measured as the change in HBI scores from baseline to week 4. A clinical response is defined as reduction of at least 3 points in HBI score, ∆HBI\>3 in patients with baseline HBI\>7. Harvey-Bradshaw Index (HBI) is a tool for assessing the degree of illness (activity) in patient's with Crohn's disease. Higher score means higher disease activity and severity. A drop \> 3 is considered a clinical response.
Determine patients clinical response rates using Harvey-Bradshaw Index (HBI) in Crohn's disease patients receiving cannabis at week 12
时间窗: week 12
Disease clinical response will be measured as the change in HBI scores from baseline to week 12. A clinical response is defined as reduction of at least 3 points in HBI score, ∆HBI\>3 in patients with baseline HBI\>7. Harvey-Bradshaw Index (HBI) is a tool for assessing the degree of illness (activity) in patient's with Crohn's disease. Higher score means higher disease activity and severity. A drop \> 3 is considered a clinical response.
Determine the clinical response rates using SCCAI (Simple Clinical Colitis Activity Index) in patients with Ulcerative Colitis receiving cannabis at week 12
时间窗: week 12
Disease clinical response will be measured as the change in SCCAI scores from baseline to week 12. A clinical response is defined as reduction of at list 30% in SCCAI score, ∆SCCAI\>30% for Ulcerative Colitis SCCAI (Simple Clinical Colitis Activity Index) is used to assess the severity of symptoms in people who suffer from ulcerative colitis. Score range from 0 to 19 points 0\<SCCAI\<19. Higher score means higher disease activity and severity.
次要结局
- Determine endoscopic response rates using Mayo score in patients with Ulcerative Colitis receiving cannabis at weeks 12(week 12)
- Determine endoscopic response rates using Simple Endoscopic Score for Crohn's Disease (SES-CD) in patients with Crohn's disease receiving cannabis at weeks 24(week 24)
- Determine clinical remission rates using Harvey-Bradshaw Index (HBI) in Crohn's disease patients receiving cannabis at weeks 4(week 4)
- Determine clinical remission rates using Harvey-Bradshaw Index (HBI) in Crohn's disease patients receiving cannabis at weeks 24(week 24)
- Determine endoscopic response rates using Simple Endoscopic Score for Crohn Disease (SES-CD) in patients with Crohn's disease receiving cannabis at weeks 4(week 4)
- Determine endoscopic response rates using Mayo score in patients with Ulcerative Colitis receiving cannabis at weeks 4(week 4)
- Determine clinical remission rates using SCCAI (Simple Clinical Colitis Activity Index) in patients with Ulcerative Colitis receiving cannabis at week 12(week 12)
- Determine clinical remission rates SCCAI (Simple Clinical Colitis Activity Index) in patients with Ulcerative Colitis receiving cannabis at week 24(week 24)
- Determine endoscopic response rates using Simple Endoscopic Score for Crohn Disease (SES-CD) in patients with Crohn's disease receiving cannabis at weeks 12(week 12)
- Determine endoscopic remission rates using Mayo score in patients with Ulcerative Colitis receiving cannabis at weeks 4(week 4)
- Determine clinical remission rates using SCCAI (Simple Clinical Colitis Activity Index) in patients with Ulcerative Colitis receiving cannabis at week 4(week 4)
- Determine clinical remission rates using Harvey-Bradshaw Index (HBI) in Crohn's disease patients receiving cannabis at weeks 12(week 12)
- Determine endoscopic response rates using Mayo score in patients with Ulcerative Colitis receiving cannabis at weeks 24(week 24)
- Determine endoscopic remission rates using Simple Endoscopic Score for Crohn's Disease (SES-CD) in patients with Crohn's disease receiving cannabis at week 4(week 4)
- Determine endoscopic remission rates using Mayo score in patients with Ulcerative Colitis receiving cannabis at weeks 12(week 12)
- Determine endoscopic remission rates using Simple Endoscopic Score for Crohn's Disease (SES-CD) in patients with Crohn's disease receiving cannabis at week 24(week 24)
- Determine endoscopic remission rates using Simple Endoscopic Score for Crohn's Disease (SES-CD) in patients with Crohn's disease receiving cannabis at week 12(week 12)
- Determine endoscopic remission rates using Mayo score in patients with Ulcerative Colitis receiving cannabis at weeks 24(week 24)
研究者
Eli Sprecher, MD
PI
Tel-Aviv Sourasky Medical Center