Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Palmitoylethanolamide in Ulcerative Colitis

11 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • El-Abbasia
      • Cairo, El-Abbasia, Egipto, 11252
        • Reclutamiento
        • Internal Medicine and Gastroenterology clinic, El-Demerdash Hospital
        • Contacto:
        • Sub-Investigador:
          • Hagar Ahmed Elessawy, Associate professor

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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
Comparador de placebos: 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Clinical response
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Serum C-reactive protein (CRP)
Periodo de tiempo: 3 months
The change in serum C-reactive protein (CRP)
3 months
Serum pentraxin-3 (PTX-3)
Periodo de tiempo: 3 months
The change in serum pentraxin-3 (PTX-3)
3 months
Fecal calprotectin (FCP)
Periodo de tiempo: 3 months
The change in fecal calprotectin (FCP)
3 months
Clinical remission
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Director de estudio: Sarah Farid Mohammed, Associate professor, Faculty of Pharmacy, Ain-Shams University
  • Director de estudio: Hagar Ahmed Elessawy, Associate professor, Faculty of Medicine, Ain-Shams University
  • Director de estudio: Nagwa Ali Sabri, Professor, Faculty of Pharmacy, Ain-Shams University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de agosto de 2026

Finalización primaria (Estimado)

15 de diciembre de 2028

Finalización del estudio (Estimado)

15 de febrero de 2029

Fechas de registro del estudio

Enviado por primera vez

20 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

20 de mayo de 2026

Publicado por primera vez (Actual)

27 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

11 de septiembre de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir