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Not Yet Recruiting NCT07609810

Palmitoylethanolamide in Ulcerative Colitis

Conditions: Ulcerative Colitis (UC)

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Ain Shams University

Location: Internal Medicine and Gastroenterology clinic, El-Demerdash Hospital Cairo El-Abbasia

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, steroid-dependent defined as unable to reduce steroids below the equivalent of prednisolone 10 mg/day or budesonide below 3 mg/day within 3 months of starting steroids, without recurrent active disease or who have a relapse within 3 months of stopping steroids and they currently take azathioprine. 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).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07609810). StuddyBuddy aggregates publicly available trial information.