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