IBD (general)Recruiting
Effects of Phytocannabinoids on Immune Response and Autophagy During Chronic Immune-mediated Inflammatory Diseases
Observational · No treatment assigned · 1 site · Centre Hospitalier Régional d'Orléans
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Disorder of Immune System, Spondylitis, Ankylosing and Arthritis, Rheumatoid. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Male or female ≥ 18 years old
- Diagnosis confirmed by a rheumatologist of RA or spondyloarthropathy (with or without IBD) or psoriatic arthritis (with or without active psoriasis) or systemic lupus erythematosus or Sjögren's disease
- Patient who has expressed consent to participate in the study
Plus 2 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 100 participants are expected to take part.
- Start date: 2025-04-10.
- Main results expected around 2027-04-09 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Main thing being measured
- The primary outcome is to evaluate the biological effect of exposure of blood cells from patients suffering from IMID to different varieties of pCB extracts on the inflammatory profile. (One sample at inclusion for all patients)
In the researchers’ words
Cannabis, in addition to its psychotropic properties, could have anti-inflammatory and immunomodulatory effects. Phytocannabinoids (pCBs) are a group of molecules naturally secreted by the cannabis plant.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Disorder of Immune System; Spondylitis, Ankylosing; Arthritis, Rheumatoid; Arthritis, Psoriatic; Inflammatory Bowel Diseases; Sjogren's Syndrome; Lupus Erythematosus, Systemic |
| Lead sponsor | Centre Hospitalier Régional d'Orléans |
| Enrollment | 100 (estimated) |
| Start date | 2025-04-10 |
| Primary completion (est.) | 2027-04-09 |
| First posted | 2025-02-24 |
| Last updated | 2025-12-30 |
| Official title | In Vitro Effects of Phytocannabinoids on Immune Response and Autophagy During Chronic Immune-mediated Inflammatory Diseases |
| ClinicalTrials.gov ID | NCT06842316 |
Interventions
- 1 blood sample, 40 mL (collection during a blood test, part of the standard of care for this disease) (Other)
Mononuclear and polynuclear peripheral blood cells from subjects suffering from IMID will be exposed in vitro to different inflammatory inducers with and without the concomitant addition of at least 4 different pCB extracts spectrum complete (full spectrum) including a dominant CBD extract and low in THC (<0.2%), 1 dominant THC extract, 1 balanced THC/CBD extract and 1 dominant CBG extract. The sa…
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Male or female ≥ 18 years old 2. Diagnosis confirmed by a rheumatologist of RA or spondyloarthropathy (with or without IBD) or psoriatic arthritis (with or without active psoriasis) or systemic lupus erythematosus or Sjögren's disease 3. Patient who has expressed consent to participate in the study 4. Patients affiliated to social security 5. Treatments authorized as part of routine care: non-steroidal anti-inflammatory drugs (NSAIDs), level 1 to 3 analgesics, local corticosteroids, oral corticosteroid therapy (daily dose ≤15 mg/d), 5-aminosalicylic acid, salazopyrine, methotrexate, leflunomide, hydroxychloroquine, biotherapies and targeted therapies. Exclusion Criteria: 1. Patient who received intravenous corticosteroid therapy less than 4 weeks ago 2. Patient receiving oral corticosteroid therapy with a daily dose >15 mg/day 3. Consumption of CBD and/or recreational cannabis and/or positive saliva test for cannabis consumption and/or CBD 4. Pregnant and lactating women 5. Persons under guardianship or curatorship
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| CHU d'ORLEANS | Orléans | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.