Palmitoylethanolamide in Ulcerative Colitis
Recruiting · NCT07609810 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Palmitoylethanolamide (PEA)Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 ≥ 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).
Where it is running
1 location listed.
- Internal Medicine and Gastroenterology clinic, El-Demerdash Hospital - Cairo, El-Abbasia, Egypt