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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active mild-to-moderate ulcerative colitis who are not responding to 5-ASA drugs and take 5-ASAs with corticosteroids.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Confirmed ulcerative colitis, active and mild-to-moderate (SCCAI score ≥ 5 and < 12 at screening).
- Earlier treatment
- Not responding to 5-aminosalicylates (5-ASA): rectal bleeding lasting beyond 2 weeks, or no lasting relief after 40 days of 5-ASA treatment. Taking 5-ASAs together with corticosteroids. People never treated for UC and people on biologics cannot join.
Main reasons for not taking part
- Pregnancy or breastfeeding
- Severe or acute severe colitis needing hospital care, or needing colectomy
- Crohn disease or other inflammatory conditions of the gut
- Kidney or liver disease, or other autoimmune diseases
- Taking NSAIDs or aspirin
Read by machine on 13 November 2026.
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, EgyptContact: Ahmed Emad Sayed, Teaching AssistantTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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).