๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Confirmed diagnosis of ulcerative colitis (UC) by established clinical and endoscopic criteria.
* Active mild-to-moderate UC patients defined by a SCCAI score โฅ 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 (Harbord et al., 2017), receiving a combination of 5-ASAs and corticosteroids.
Exclusion Criteria:
* Pregnancy or breastfeeding.
* Alcohol or drug abuse.
* Allergy or known hypersensitivity to palmitoylethanolamide.
* Active infection (enteric or systemic).
* Uncontrolled metabolic/ neurologic conditions: uncontrolled hypertension, uncontrolled diabetes, migraine disorders or other uncontrolled neurologic disease.
* Other autoimmune diseases.
* Severe or acute severe colitis requiring hospitalization.
* UC patients requiring colectomy.
* Crohn disease (CD), chronic pancreatitis, cholecystitis or other inflammatory conditions involving the gastrointestinal tract (GIT).
* Patients with renal or liver disease.
* Patients who have never been treated for UC.
* Any patients on biologics.
* Patients using NSAIDs or aspirin (due to interference with fecal calprotectin results).
๐
What it tests
- Palmitoylethanolamide (PEA)
- Placebo
Internal Medicine and Gastroenterology clinic, El-Demerdash Hospital
Cairo, Egypt
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.