UnknownNot Applicable

Inflammatory Bowel Diseases (IBD) Cannabis Registry

Israel1,000 participantsStarted 2019-07-10

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Determine patients clinical response rates using Harvey-Bradshaw Index (HBI) in Crohn's disease patients receiving cannabis at week 4

Timeframe: week 4

Determine the clinical response rates using SCCAI (Simple Clinical Colitis Activity Index) in patients with Ulcerative Colitis receiving cannabis at week 4

Timeframe: week 4

Determine patients clinical response rates using Harvey-Bradshaw Index (HBI) in Crohn's disease patients receiving cannabis at week 12

Timeframe: week 12

Determine the clinical response rates using SCCAI (Simple Clinical Colitis Activity Index) in patients with Ulcerative Colitis receiving cannabis at week 12

Timeframe: week 12

Determine patients clinical response rates using Harvey-Bradshaw Index (HBI) in Crohn's disease patients receiving cannabis at week 24

Timeframe: Week 24

Determine the clinical response rates using SCCAI (Simple Clinical Colitis Activity Index) in patients with Ulcerative Colitis receiving cannabis at week 24

Timeframe: Week 24

Trial details

NCT IDNCT05578313

SponsorEli Sprecher, MD

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2023-07-10

Contact for this trial

Nitsanm Maharshak, Professor

+972527360384 nitsanm@tlvmc.gov.il

View on ClinicalTrials.gov More Crohn Disease trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Determine patients clinical response rates using Harvey-Bradshaw Index (HBI) in Crohn's disease patients receiving cannabis at week 4

Timeframe: week 4

Determine the clinical response rates using SCCAI (Simple Clinical Colitis Activity Index) in patients with Ulcerative Colitis receiving cannabis at week 4

Timeframe: week 4

Determine patients clinical response rates using Harvey-Bradshaw Index (HBI) in Crohn's disease patients receiving cannabis at week 12

Timeframe: week 12

Determine the clinical response rates using SCCAI (Simple Clinical Colitis Activity Index) in patients with Ulcerative Colitis receiving cannabis at week 12

Timeframe: week 12

Determine patients clinical response rates using Harvey-Bradshaw Index (HBI) in Crohn's disease patients receiving cannabis at week 24

Timeframe: Week 24

Determine the clinical response rates using SCCAI (Simple Clinical Colitis Activity Index) in patients with Ulcerative Colitis receiving cannabis at week 24

Timeframe: Week 24