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Palmitoylethanolamide in Ulcerative Colitis

11 septembre 2026 mis à jour par: Ahmed Emad, Ain Shams University

The Effect of Palmitoylethanolamide on the Clinical Outcomes in Ulcerative Colitis Patients

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.

Aperçu de l'étude

Description détaillée

Ulcerative colitis (UC) is a chronic immune-mediated inflammatory bowel disease (IBD) of the large intestine characterized by a continuous pattern of mucosal and submucosal inflammation and ulceration involving the distal, the proximal or even the entire colon. It is reported to commonly affect people aged 15-30 years with a slight male predominance. The global prevalence rate of UC is estimated to be about 120 per 100,000 as of 2025 with a rapidly rising incidence especially in industrialized regions. It follows a relapsing-remitting course and commonly presents with abdominal pain, bloody diarrhea, urgency, and tenesmus. Although its etiology is poorly understood, multiple factors are thought to be implicated in its pathogenesis including genetic susceptibility, environmental factors such as diet, infections, medications…etc. and changes in intestinal microbiome composition which trigger an overreactive immune response damaging the mucosal barrier, and genetic susceptibility.

Multiple modalities are utilized in the pharmacological management of UC targeting the local and systemic chemical mediators of inflammation like 5-aminosalicylates, corticosteroids, immunomodulators and biologics. Molecular targets like: TNF-α, IL-6, IL-12, IL-17, IL-23, leukotrienes and integrins have been extensively studied which led to the development of therapeutic ligands. Interestingly, peroxisome proliferator-activated receptor- α (PPAR-α), a member of nuclear hormone receptor superfamily of ligand-activated transcription factors, is a promising target investigated in animal models for its anti-inflammatory and protective effects. Activation of such receptor is thought to reduce NO production, neutrophil influx, and decrease the expression of proinflammatory proteins, such as inducible NO synthase (iNOS), cyclo-oxygenase-2 (COX-2) and TNF- α.

The currently approved interventions can only calm down the underlying abnormal immune response and the associated inflammation successfully achieving remission. However, they cannot completely eradicate the cause of autoimmunity or restore the regular immune balance. Their use, especially biologics, is associated with loss of efficacy over time due to possible immunogenicity, high risk of infection and allergic reactions. Multisystem side effects are also commonly seen with corticosteroids' use particularly in the long term. Therefore, the focus has shifted in recent years towards complementary and alternative medicine in order to provide safe and reliably effective options.

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) and transient receptor potential vanilloid receptor 1 (TRPVR1) channels. PEA is a commercially available supplement mainly used to alleviate chronic neuropathic pain and persistent musculoskeletal pain. PEA has proven to be safe and tolerable across multiple studies with very rare cases reporting mild side effects like: intermittent headache, nausea, constipation, urticaria and fatigue.

PEA has demonstrated broad analgesic and anti-inflammatory effects across multiple conditions. It effectively reduces diabetic peripheral neuropathic pain, chronic pain in knee osteoarthritis, and cutaneous adverse effects related to interferon-β therapy in multiple sclerosis in previous clinical trials, while also lowering circulating pro-inflammatory cytokines. PEA has further shown the ability to attenuate inflammatory, oxidative stress, and serological biomarkers in early COVID-19. In gastrointestinal disorders, particularly irritable bowel syndrome (IBS), PEA -especially when combined with polydatin- significantly alleviates abdominal pain in pediatrics. Experimental evidence from murine colitis models and ex-vivo human and animal colonic tissues suggests a potential therapeutic role for PEA in UC. Its anti-inflammatory action is mainly mediated through selective activation of PPAR-α, leading to suppression of enteroglial S100B release, inhibition of toll-like receptor signaling, and downstream inflammatory pathways. Additionally, PEA may exert anti-angiogenic effects and provide protection against colonic carcinogenesis by reducing VEGF release via modulation of the AKT/mTOR pathway.

Type d'étude

Interventionnel

Inscription (Estimé)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

    • El-Abbasia
      • Cairo, El-Abbasia, Egypte, 11252
        • Recrutement
        • Internal Medicine and Gastroenterology clinic, El-Demerdash Hospital
        • Contact:
        • Sous-enquêteur:
          • Hagar Ahmed Elessawy, Associate professor

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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).

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Intervention group
30 patients will receive palmitoylethanolamide (PEA® hard gelatin capsules) 600 mg/day in addition to their standard therapy according to the European Crohn and Colitis Organization (ECCO) guidelines for 3 months. Standard therapy consists of: 5-Aminosalicylates, corticosteroids and azathioprine.
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) and transient receptor potential vanilloid receptor 1 (TRPVR1) channels. PEA is a commercially available supplement mainly used to alleviate chronic neuropathic pain and persistent musculoskeletal pain. PEA has proven to be safe and tolerable across multiple studies with very rare cases reporting mild side effects like: intermittent headache, nausea, constipation, urticaria and fatigue. It will be given in this study at a dose of 600 mg/day
Comparateur placebo: Placebo group
30 patients will receive placebo capsules in addition to their standard therapy according to the ECCO guidelines for 3 months. Standard therapy consists of: 5-Aminosalicylates, corticosteroids and azathioprine.
Placebo capsules matching the active treatment

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Clinical response
Délai: 3 months
The percentage of patients who achieved clinical response or improvement defined by a drop of ≥ 3 points in the Simple Clinical Colitis Activity Index (SCCAI) score
3 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Serum C-reactive protein (CRP)
Délai: 3 months
The change in serum C-reactive protein (CRP)
3 months
Serum pentraxin-3 (PTX-3)
Délai: 3 months
The change in serum pentraxin-3 (PTX-3)
3 months
Fecal calprotectin (FCP)
Délai: 3 months
The change in fecal calprotectin (FCP)
3 months
Clinical remission
Délai: 3 months
The percentage of patients who achieved clinical remission defined by a Simple Clinical Colitis Activity Index (SCCAI) score ≤ 2
3 months
Change in disease activity
Délai: 3 months
The change in the Simple Clinical Colitis Activity Index (SCCAI) score (The score ranges from 0-19, where higher scores indicate increased disease activity and vice versa)
3 months
Health-related quality of life (HRQoL)
Délai: 3 months
The change in the Short Inflammatory Bowel Disease Questionnaire (SIBDǪ) score (The score ranges from 10 which indicates a very poor quality of life to 70 which indicates optimal functioning and quality of life i.e. Higher scores indicate improved patient health-related quality of life (HRQoL) and vice versa)
3 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Directeur d'études: Sarah Farid Mohammed, Associate professor, Faculty of Pharmacy, Ain-Shams University
  • Directeur d'études: Hagar Ahmed Elessawy, Associate professor, Faculty of Medicine, Ain-Shams University
  • Directeur d'études: Nagwa Ali Sabri, Professor, Faculty of Pharmacy, Ain-Shams University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

15 août 2026

Achèvement primaire (Estimé)

15 décembre 2028

Achèvement de l'étude (Estimé)

15 février 2029

Dates d'inscription aux études

Première soumission

20 mai 2026

Première soumission répondant aux critères de contrôle qualité

20 mai 2026

Première publication (Réel)

27 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 septembre 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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