NCT06842316 Effects of Phytocannabinoids on Immune Response and Autophagy During Chronic Immune-mediated Inflammatory Diseases
| NCT ID | NCT06842316 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Régional d'Orléans |
| Condition | Inflammatory Disorder of Immune System |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-04-10 |
| Primary Completion | 2027-04-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-04-10 with a primary completion date of 2027-04-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. The major pCBs are cannabidiol (CBD) and Δ9-tetrahydrocannabinol Δ9 (THC). Only THC has psychotropic effects, which CBD does not have. Alongside these two main components, there is a wide variety of other molecules, such as other pCBs and terpenes which could increase the effects on immune system through synergistic interactions between these different compounds ("entourage effect").In vivo, pCBs essentially interfere with the endocannabinoid system, acting on many ubiquitous receptors, present on a significant number of different cell types. Numerous published studies show that pCBs have immunomodulatory and anti-inflammatory properties by acting on several of these receptors, whether through modulation of the immune response of different cell types, effects on cytokine networks, reduction of innate and adaptive responses and/or impact on cell survival or death (autophagy, proliferation/ apoptosis). The Immune-Mediated Inflammatory Diseases (IMIDs) affect 5 to 7% of the general population in Western countries, involve different organs (joints, skin, digestive tract) but share the same inflammatory mechanisms resulting from a dysregulation of the immune response. Our research focuses on the identification of the most effective phytochemical profile of pCBs, allowing an optimal effect on chronic inflammatory pathologies of interest among immune-mediated chronic inflammatory diseases (IMIDs). The pCB-IMIDs project is therefore part of an innovative translational project, around new therapeutic applications of medical cannabis (CannAppIMIDs). In our study, we will include 100 patients with one of IMIDs among Rheumatoid Arthritis, spondylarthritis, psoriatic arthritis, Sjogren disease and systemic lupus, at different stage and with different treatments. After patient's consent we will collect for research purposes an additional 40 ml of blood during a routine care blood test. Mononuclear and polynucleated blood cells will be exposed in vitro to different full-spectrum pCB extracts (full spectrum extract) including a CBD dominant and low THC extract (\<0.2%), 1 dominant THC extract, 1 balanced THC/CBD extract and 1 dominant CBG extract. In this cross-sectional study, our objective will be to assess the biological effects of different pCB compositions on inflammatory profiles (concentrations of pro and anti-inflammatory cytokines and chemokines) and modulations of expression profiles (autophagy, apoptosis, and cannabinoid receptor expression profile).
Eligibility Criteria
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
Contact & Investigator
Carine Pr SALLIOT
PRINCIPAL INVESTIGATOR
CHU Orléans
Frequently Asked Questions
Who can join the NCT06842316 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inflammatory Disorder of Immune System. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06842316 currently recruiting?
Yes, NCT06842316 is actively recruiting participants. Contact the research team at carine.salliot@chu-orleans.fr for enrollment information.
Where is the NCT06842316 trial being conducted?
This trial is being conducted at Orléans, France.
Who is sponsoring the NCT06842316 clinical trial?
NCT06842316 is sponsored by Centre Hospitalier Régional d'Orléans. The principal investigator is Carine Pr SALLIOT at CHU Orléans. The trial plans to enroll 100 participants.