Palmitoylethanolamide in Ulcerative Colitis
Not applicable · Testing Palmitoylethanolamide (PEA) · 1 site · Ain Shams University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Palmitoylethanolamide (PEA) (a dietary supplement) as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC).
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 65
- Any sex
Some of the main requirements, copied from the record:
- 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…
There are also 13 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 60 participants are expected to take part.
- Start date: 2026-08-15 (planned).
- Main results expected around 2028-12-15 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Egypt.
Main thing being measured
- Clinical response (3 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC) |
| Lead sponsor | Ain Shams University |
| Enrollment | 60 (estimated) |
| Start date | 2026-08-15 |
| Primary completion (est.) | 2028-12-15 |
| First posted | 2026-05-27 |
| Last updated | 2026-09-15 |
| Official title | The Effect of Palmitoylethanolamide on the Clinical Outcomes in Ulcerative Colitis Patients |
| ClinicalTrials.gov ID | NCT07609810 |
Interventions
- Palmitoylethanolamide (PEA) (Dietary Supplement)
Palmitoylethanolamide (PEA) is an endocannabinoid-like bioactive lipid mediator which belongs to the family of N-acylethanolamine (NAE) fatty acid amides. It exerts anti-inflammatory, antioxidant, antimicrobial, analgesic, immunomodulatory and neuroprotective actions through acting at different sites like: PPAR-α, G-protein coupled receptor 55 (GPR55), cannabinoid receptors 1 and 2 (CB1 and CB2) a… - Placebo (Other)
Placebo capsules matching the active treatment
Full eligibility criteria (from the record)
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).
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Internal Medicine and Gastroenterology clinic, El-Demerdash Hospital | Cairo, El-Abbasia | Egypt | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.