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Palmitoylethanolamide in Ulcerative Colitis

2026년 7월 13일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • El-Abbasia
      • Cairo, El-Abbasia, 이집트, 11252
        • Internal Medicine and Gastroenterology clinic, El-Demerdash Hospital
        • 연락하다:
        • 부수사관:
          • Hagar Ahmed Elessawy, Associate professor

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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
위약 비교기: 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Clinical response
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Serum C-reactive protein (CRP)
기간: 3 months
The change in serum C-reactive protein (CRP)
3 months
Serum pentraxin-3 (PTX-3)
기간: 3 months
The change in serum pentraxin-3 (PTX-3)
3 months
Fecal calprotectin (FCP)
기간: 3 months
The change in fecal calprotectin (FCP)
3 months
Clinical remission
기간: 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
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 15일

기본 완료 (추정된)

2028년 12월 15일

연구 완료 (추정된)

2029년 2월 15일

연구 등록 날짜

최초 제출

2026년 5월 20일

QC 기준을 충족하는 최초 제출

2026년 5월 20일

처음 게시됨 (실제)

2026년 5월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 13일

마지막으로 확인됨

2026년 5월 1일

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