Inflammatory Bowel Diseases (IBD) Cannabis Registry

NCT05578313 | Unknown

• 1 other identifier: TLV_0276-19
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn Disease; Ulcerative Colitis; Pouchitis; Healthy

Outcome Measures

Primary Outcomes (6)

• Determine patients clinical response rates using Harvey-Bradshaw Index (HBI) in Crohn's disease patients receiving cannabis at 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.

  week 4

• Determine the clinical response rates using SCCAI (Simple Clinical Colitis Activity Index) in patients with Ulcerative Colitis receiving cannabis at 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.

  week 4

• Determine patients clinical response rates using Harvey-Bradshaw Index (HBI) in Crohn's disease patients receiving cannabis at 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.

  week 12

• Determine the clinical response rates using SCCAI (Simple Clinical Colitis Activity Index) in patients with Ulcerative Colitis receiving cannabis at 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.

  week 12

• Determine patients clinical response rates using Harvey-Bradshaw Index (HBI) in Crohn's disease patients receiving cannabis at 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.

  Week 24

• Determine the clinical response rates using SCCAI (Simple Clinical Colitis Activity Index) in patients with Ulcerative Colitis receiving cannabis at 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.

  Week 24

Secondary Outcomes (18)

• 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 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 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 using Harvey-Bradshaw Index (HBI) in Crohn's disease patients receiving cannabis at weeks 24

  week 24

Other Outcomes (12)

• Assess the effect of cannabis treatment on pain levels using visual analog scale (VAS) in patients with IBD, after 1 month of treatment

  week 4

• Assess the effect of cannabis treatment on pain levels using visual analog scale (VAS) in patients with IBD, after 3 month of treatment

  week 12

• Assess the effect of cannabis treatment on pain levels using visual analog scale (VAS) in patients with IBD, after 6 month of treatment

  week 24

Study Arms (5)

• Group 1 (study group)

IBD patients prescribed cannabis as treatment of their bowel disease.

Drug: Medical Cannabis

• Group 2 (Control group)

One hundred healthy patients who do not use cannabis and are not eligible or not interested to commence this intervention.

• Group 3 (control group)

Up to 100 IBD patient who experience pain and do not use cannabis

• Group 4 (control group)

Up to 100 IBD patient who do not experience pain and do not use cannabis

• Group 5 (Cannabis responders group)

up to 100 IBD patients previously prescribed cannabis and were identified to have positive effect on their disease

Interventions

Medical Cannabis DRUG

Patients will be observed throughout their treatment with medical cannabis, prescribed to them by for clinically treating their disease (treatment is not an intervention of the study).

• Group 1 (study group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population: Eligible IBD patients treated at the IBD clinic in the Tel Aviv Medical Center participating in the study, which have signed an informed consent form and answered to all the study inclusion criteria. Patients will be informed of the study by their treating physician, recruited and followed throughout the follow-up period by study co-ordinators. This study will include five patient groups:

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Sprecher, MD: lead

Study Sites (1)

Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Baseline and follow up study visits will include biologic samples collection (blood, feces) from which blood levels of complete blood count (CBC), Albumin, Liver enzymes (ALT, AST, ALP), lipid panel (Total cholesterol, LDL, HDL, triglycerides), creatinine, fasting glucose, C-reactive protein (CRP), drug levels and antibodies (for patients treated with thiopurines and biologics), and fecal levels of Calprotectin will be measured. White blood cells will be separated and stored for mRNA analysis of cannabinoid metabolism. Only RNA fractions will be extracted and analyzed, no DNA will be assessed and no genetic sequencing will be performed

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Pouchitis

Interventions

Medical Marijuana

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Ileitis; Enteritis; Ileal Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Central Study Contacts

Nitsanm Maharshak, Professor

CONTACT

+972527360384; nitsanm@tlvmc.gov.il

Naomi Fliss, Doctor

CONTACT

+972524626445; naomifl@tlvmc.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: October 13, 2022
• Study Start: July 10, 2019
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2024
• Last Updated: October 13, 2022

Record last verified: 2022-10

Locations

IL (1)