About this trial
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.
Eligibility criteria
Qualifiers
Confirmed diagnosis of ulcerative colitis (UC) by established clinical and endoscopic criteria.
Active mild-to-moderate UC patients defined by a SCCAI score ≥ 5 and < 12 at screening, not responding to 5-aminosalicylates (5-ASA) defined as persistent rectal bleeding beyond 2 weeks or failure to achieve sustained symptom relief after 40 days of appropriate 5-ASA therapy, steroid-dependent defined as unable to reduce steroids below the equivalent of prednisolone 10 mg/day or budesonide below 3 mg/day within 3 months of starting steroids, without recurrent active disease or who have a relapse within 3 months of stopping steroids and they currently take azathioprine.
Disqualifiers
Pregnancy or breastfeeding.
Alcohol or drug abuse.
Allergy or known hypersensitivity to palmitoylethanolamide.
Active infection (enteric or systemic).
Trial design
Treatments tested in this trial
- Palmitoylethanolamide (PEA)