Palmitoylethanolamide supplement for mild-to-moderate active ulcerative colitis
Tests palmitoylethanolamide against a placebo in adults with active ulcerative colitis.
Plain-language title generated from the registry record
Registry title: Palmitoylethanolamide in Ulcerative Colitis
Key facts
- Where
- Cairo, EgyptSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07609810, who can take part
Where in Egypt
- Internal Medicine and Gastroenterology clinic, El-Demerdash HospitalCairo, EgyptTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ain Shams University
- Trial code
- NCT07609810
- Record updated
- 15 September 2026
- Original description
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.Read full original descriptionShow less
The Effect of Palmitoylethanolamide on the Clinical Outcomes in Ulcerative Colitis Patients
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.
Inclusion: 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: 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; Crohn disease (CD), chronic pancreatitis, cholecystitis or other inflammatory conditions involving the gastrointestinal tract (GIT); Patients with renal or liver disease; Pregnancy or breastfeeding; Severe or acute severe colitis requiring hospitalization; UC patients requiring colectomy; Patients who have never been treated for UC; Any patients on biologics; Patients using NSAIDs or aspirin (due to interference with fecal calprotectin results).