NCT07609810 Palmitoylethanolamide in Ulcerative Colitis
| NCT ID | NCT07609810 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ain Shams University |
| Condition | Ulcerative Colitis (UC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-08-15 |
| Primary Completion | 2028-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-08-15 with a primary completion date of 2028-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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).
Contact & Investigator
Sarah Farid Mohammed, Associate professor
STUDY DIRECTOR
Faculty of Pharmacy, Ain-Shams University
Frequently Asked Questions
Who can join the NCT07609810 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Ulcerative Colitis (UC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07609810 currently recruiting?
Yes, NCT07609810 is actively recruiting participants. Contact the research team at ahmed.emad18@pharma.asu.edu.eg for enrollment information.
Where is the NCT07609810 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07609810 clinical trial?
NCT07609810 is sponsored by Ain Shams University. The principal investigator is Sarah Farid Mohammed, Associate professor at Faculty of Pharmacy, Ain-Shams University. The trial plans to enroll 60 participants.
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