Palmitoylethanolamide in Ulcerative Colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares palmitoylethanolamide (PEA) to placebo in adults with active mild-to-moderate ulcerative colitis who have not fully responded to 5-ASA therapy. Participants will receive PEA or placebo and will be followed to measure changes in disease activity, HRQoL, and inflammatory biomarkers. The trial is conducted at Ain Shams University and El-Demerdash Hospital in Cairo. Primary outcomes focus on disease activity indices, with secondary outcomes including quality of life and biomarker changes. Eligible patients must have UC confirmed by clinical and endoscopic criteria and meet defined activity thresholds.

Why it matters

Who can join: the full rules

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's running

• Internal Medicine and Gastroenterology clinic, El-Demerdash Hospital
  Cairo, El-Abbasia, Egypt Recruiting

Study contacts

• Study coordinator: Ahmed Emad Sayed, Teaching Assistant
• Email: ahmed.emad18@pharma.asu.edu.eg
• Phone: +201007546334

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.