NCT07609810Recruiting
Palmitoylethanolamide in Ulcerative Colitis
The Effect of Palmitoylethanolamide on the Clinical Outcomes in Ulcerative Colitis Patients
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 20 May 2026
- Start date
- 15 Aug 2026
- Primary completion date
- 15 Dec 2028
- Lead sponsor
- Ain Shams University
- Diseases
- Ulcerative colitis
- NCT number
- NCT07609810
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 15 Aug 2026 to the primary completion date, 15 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Alcohol or drug abuse.
Other illness
- 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.
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Internal Medicine and Gastroenterology clinic, El-Demerdash Hospital Coordinator of this site? Confirm its status | Cairo | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.