Palmitoylethanolamide in Ulcerative Colitis
NCT07609810 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-05-28
Summary
Evaluate the effects of PEA supplementation on disease activity, health-related quality of life (HRQoL) and inflammatory biomarkers in patients with active mild-to-moderate UC.
Conditions
- Ulcerative Colitis (UC)
Interventions
- DIETARY_SUPPLEMENT
-
Palmitoylethanolamide (PEA)
Palmitoylethanolamide (PEA) is an endocannabinoid-like bioactive lipid mediator which belongs to the family of N-acylethanolamine (NAE) fatty acid amides. It exerts anti-inflammatory, antioxidant, antimicrobial, analgesic, immunomodulatory and neuroprotective actions through acting at different sites like: PPAR-α, G-protein coupled receptor 55 (GPR55), cannabinoid receptors 1 and 2 (CB1 and CB2) and transient receptor potential vanilloid receptor 1 (TRPVR1) channels. PEA is a commercially available supplement mainly used to alleviate chronic neuropathic pain and persistent musculoskeletal pain. PEA has proven to be safe and tolerable across multiple studies with very rare cases reporting mild side effects like: intermittent headache, nausea, constipation, urticaria and fatigue. It will be given in this study at a dose of 600 mg/day
Sponsors & Collaborators
-
Ain Shams University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-15
- Primary Completion
- 2028-12-15
- Completion
- 2029-02-15
Countries
- Egypt
Study Locations
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