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โ† Trials
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Palmitoylethanolamide in Ulcerative Colitis

RecruitingNAAges 18 Years - 65 YearsAllAin Shams University
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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).
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What it tests

  • Palmitoylethanolamide (PEA)
  • Placebo
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Where

1 site
Internal Medicine and Gastroenterology clinic, El-Demerdash Hospital
Cairo, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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