- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07609810
Palmitoylethanolamide in Ulcerative Colitis
The Effect of Palmitoylethanolamide on the Clinical Outcomes in Ulcerative Colitis Patients
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Ahmed Emad, Teaching Assistant
- Telefonní číslo: +201007546334
- E-mail: ahmed.emad18@pharma.asu.edu.eg
Studijní místa
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El-Abbasia
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Cairo, El-Abbasia, Egypt, 11252
- Internal Medicine and Gastroenterology clinic, El-Demerdash Hospital
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Kontakt:
- Ahmed Emad, Teaching Assistant
- Telefonní číslo: +201007546334
- E-mail: ahmed.emad18@pharma.asu.edu.eg
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Vrchní vyšetřovatel:
- Ahmed Emad, Teaching Assistant
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: 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.
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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
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Žádný zásah: Control group
30 patients will receive their standard therapy according to the ECCO guidelines for 3 months.
Standard therapy consists of: 5-Aminosalicylates, corticosteroids and azathioprine.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Clinical response
Časové okno: 3 months
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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
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3 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Serum C-reactive protein (CRP)
Časové okno: 3 months
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The change in serum C-reactive protein (CRP)
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3 months
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Serum pentraxin-3 (PTX-3)
Časové okno: 3 months
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The change in serum pentraxin-3 (PTX-3)
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3 months
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Fecal calprotectin (FCP)
Časové okno: 3 months
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The change in fecal calprotectin (FCP)
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3 months
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Clinical remission
Časové okno: 3 months
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The percentage of patients who achieved clinical remission defined by a Simple Clinical Colitis Activity Index (SCCAI) score ≤ 2
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3 months
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Change in disease activity
Časové okno: 3 months
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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)
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3 months
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Health-related quality of life (HRQoL)
Časové okno: 3 months
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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)
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3 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Walmsley RS, Ayres RC, Pounder RE, Allan RN. A simple clinical colitis activity index. Gut. 1998 Jul;43(1):29-32. doi: 10.1136/gut.43.1.29.
- Guyatt G, Mitchell A, Irvine EJ, Singer J, Williams N, Goodacre R, Tompkins C. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology. 1989 Mar;96(3):804-10.
- Loftus EV Jr, Silverstein MD, Sandborn WJ, Tremaine WJ, Harmsen WS, Zinsmeister AR. Ulcerative colitis in Olmsted County, Minnesota, 1940-1993: incidence, prevalence, and survival. Gut. 2000 Mar;46(3):336-43. doi: 10.1136/gut.46.3.336.
- Irvine EJ, Zhou Q, Thompson AK. The Short Inflammatory Bowel Disease Questionnaire: a quality of life instrument for community physicians managing inflammatory bowel disease. CCRPT Investigators. Canadian Crohn's Relapse Prevention Trial. Am J Gastroenterol. 1996 Aug;91(8):1571-8.
- Gomollon F, Dignass A, Annese V, Tilg H, Van Assche G, Lindsay JO, Peyrin-Biroulet L, Cullen GJ, Daperno M, Kucharzik T, Rieder F, Almer S, Armuzzi A, Harbord M, Langhorst J, Sans M, Chowers Y, Fiorino G, Juillerat P, Mantzaris GJ, Rizzello F, Vavricka S, Gionchetti P; ECCO. 3rd European Evidence-based Consensus on the Diagnosis and Management of Crohn's Disease 2016: Part 1: Diagnosis and Medical Management. J Crohns Colitis. 2017 Jan;11(1):3-25. doi: 10.1093/ecco-jcc/jjw168. Epub 2016 Sep 22.
- Lang A, Salomon N, Wu JC, Kopylov U, Lahat A, Har-Noy O, Ching JY, Cheong PK, Avidan B, Gamus D, Kaimakliotis I, Eliakim R, Ng SC, Ben-Horin S. Curcumin in Combination With Mesalamine Induces Remission in Patients With Mild-to-Moderate Ulcerative Colitis in a Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2015 Aug;13(8):1444-9.e1. doi: 10.1016/j.cgh.2015.02.019. Epub 2015 Feb 24.
- Harbord M, Eliakim R, Bettenworth D, Karmiris K, Katsanos K, Kopylov U, Kucharzik T, Molnar T, Raine T, Sebastian S, de Sousa HT, Dignass A, Carbonnel F; European Crohn's and Colitis Organisation [ECCO]. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 2: Current Management. J Crohns Colitis. 2017 Jul 1;11(7):769-784. doi: 10.1093/ecco-jcc/jjx009. No abstract available.
- Shivashankar R, Tremaine WJ, Harmsen WS, Loftus EV Jr. Incidence and Prevalence of Crohn's Disease and Ulcerative Colitis in Olmsted County, Minnesota From 1970 Through 2010. Clin Gastroenterol Hepatol. 2017 Jun;15(6):857-863. doi: 10.1016/j.cgh.2016.10.039. Epub 2016 Nov 14.
- Heydari K, Rahnavard M, Ghahramani S, Hoseini A, Alizadeh-Navaei R, Rafati S, Raei M, Vahidipour M, Salehi F, Motafeghi F, Neshat S, Moosazadeh M, Yousefi M, Pourali A, Rasouli K, Shokrirad S, Lotfi P, Beladi SA, Hadizadeh Neisanghalb M, Sheydaee F, Moghadam S. Global prevalence and incidence of inflammatory bowel disease: a systematic review and meta-analysis of population-based studies. Gastroenterol Hepatol Bed Bench. 2025;18(2):132-146. doi: 10.22037/ghfbb.v18i2.3105.
- Steels E, Venkatesh R, Steels E, Vitetta G, Vitetta L. A double-blind randomized placebo controlled study assessing safety, tolerability and efficacy of palmitoylethanolamide for symptoms of knee osteoarthritis. Inflammopharmacology. 2019 Jun;27(3):475-485. doi: 10.1007/s10787-019-00582-9. Epub 2019 Mar 29.
- Shahrokh S, Qobadighadikolaei R, Abbasinazari M, Haghazali M, Asadzadeh Aghdaei H, Abdi S, Balaii H, Khanzadeh-Moghaddam N, Zali MR. Efficacy and Safety of Melatonin as an Adjunctive Therapy on Clinical, Biochemical, and Quality of Life in Patients with Ulcerative Colitis. Iran J Pharm Res. 2021 Spring;20(2):197-205. doi: 10.22037/ijpr.2020.113822.14508.
- Sarnelli G, D'Alessandro A, Iuvone T, Capoccia E, Gigli S, Pesce M, Seguella L, Nobile N, Aprea G, Maione F, de Palma GD, Cuomo R, Steardo L, Esposito G. Palmitoylethanolamide Modulates Inflammation-Associated Vascular Endothelial Growth Factor (VEGF) Signaling via the Akt/mTOR Pathway in a Selective Peroxisome Proliferator-Activated Receptor Alpha (PPAR-alpha)-Dependent Manner. PLoS One. 2016 May 24;11(5):e0156198. doi: 10.1371/journal.pone.0156198. eCollection 2016.
- Pickering E, Steels EL, Steadman KJ, Rao A, Vitetta L. A randomized controlled trial assessing the safety and efficacy of palmitoylethanolamide for treating diabetic-related peripheral neuropathic pain. Inflammopharmacology. 2022 Dec;30(6):2063-2077. doi: 10.1007/s10787-022-01033-8. Epub 2022 Sep 4.
- Orefice NS, Alhouayek M, Carotenuto A, Montella S, Barbato F, Comelli A, Calignano A, Muccioli GG, Orefice G. Oral Palmitoylethanolamide Treatment Is Associated with Reduced Cutaneous Adverse Effects of Interferon-beta1a and Circulating Proinflammatory Cytokines in Relapsing-Remitting Multiple Sclerosis. Neurotherapeutics. 2016 Apr;13(2):428-38. doi: 10.1007/s13311-016-0420-z.
- Moradi S, Bagheri R, Amirian P, Zarpoosh M, Cheraghloo N, Wong A, Zobeiri M, Entezari MH. Effects of Spirulina supplementation in patients with ulcerative colitis: a double-blind, placebo-controlled randomized trial. BMC Complement Med Ther. 2024 Feb 29;24(1):109. doi: 10.1186/s12906-024-04400-w.
- Lang-Illievich K, Klivinyi C, Lasser C, Brenna CTA, Szilagyi IS, Bornemann-Cimenti H. Palmitoylethanolamide in the Treatment of Chronic Pain: A Systematic Review and Meta-Analysis of Double-Blind Randomized Controlled Trials. Nutrients. 2023 Mar 10;15(6):1350. doi: 10.3390/nu15061350.
- Khazdouz M, Daryani NE, Cheraghpour M, Alborzi F, Hasani M, Ghavami SB, Shidfar F. The effect of selenium supplementation on disease activity and immune-inflammatory biomarkers in patients with mild-to-moderate ulcerative colitis: a randomized, double-blind, placebo-controlled clinical trial. Eur J Nutr. 2023 Dec;62(8):3125-3134. doi: 10.1007/s00394-023-03214-9. Epub 2023 Jul 31.
- Farsi F, Ebrahimi-Daryani N, Barati M, Janani L, Karimi MY, Akbari A, Irandoost P, Mesri Alamdari N, Agah S, Vafa M. Effects of coenzyme Q10 on health-related quality of life, clinical disease activity and blood pressure in patients with mild to moderate ulcerative colitis: a randomized clinical trial. Med J Islam Repub Iran. 2021 Jan 6;35:3. doi: 10.47176/mjiri.35.3. eCollection 2021.
- Esposito G, Capoccia E, Turco F, Palumbo I, Lu J, Steardo A, Cuomo R, Sarnelli G, Steardo L. Palmitoylethanolamide improves colon inflammation through an enteric glia/toll like receptor 4-dependent PPAR-alpha activation. Gut. 2014 Aug;63(8):1300-12. doi: 10.1136/gutjnl-2013-305005. Epub 2013 Sep 30.
- Di Nardo G, Bernardo L, Cremon C, Barbara G, Felici E, Evangelisti M, Ferretti A, Furio S, Piccirillo M, Coluzzi F, Parisi P, Mauro A, Di Mari C, D'Angelo F, Mennini M. Palmitoylethanolamide and polydatin in pediatric irritable bowel syndrome: A multicentric randomized controlled trial. Nutrition. 2024 Jun;122:112397. doi: 10.1016/j.nut.2024.112397. Epub 2024 Feb 15.
- Desai D, Faubion WA, Sandborn WJ. Review article: biological activity markers in inflammatory bowel disease. Aliment Pharmacol Ther. 2007 Feb 1;25(3):247-55. doi: 10.1111/j.1365-2036.2006.03184.x. Epub 2007 Jan 8.
- Cuzzocrea S, Di Paola R, Mazzon E, Genovese T, Muia C, Centorrino T, Caputi AP. Role of endogenous and exogenous ligands for the peroxisome proliferators activated receptors alpha (PPAR-alpha) in the development of inflammatory bowel disease in mice. Lab Invest. 2004 Dec;84(12):1643-54. doi: 10.1038/labinvest.3700185.
- Cremon C, Stanghellini V, Barbaro MR, Cogliandro RF, Bellacosa L, Santos J, Vicario M, Pigrau M, Alonso Cotoner C, Lobo B, Azpiroz F, Bruley des Varannes S, Neunlist M, DeFilippis D, Iuvone T, Petrosino S, Di Marzo V, Barbara G. Randomised clinical trial: the analgesic properties of dietary supplementation with palmitoylethanolamide and polydatin in irritable bowel syndrome. Aliment Pharmacol Ther. 2017 Apr;45(7):909-922. doi: 10.1111/apt.13958. Epub 2017 Feb 6.
- Bortoletto R, Comacchio C, Garzitto M, Piscitelli F, Balestrieri M, Colizzi M. Palmitoylethanolamide supplementation for human health: A state-of-the-art systematic review of Randomized Controlled Trials in patient populations. Brain Behav Immun Health. 2024 Dec 23;43:100927. doi: 10.1016/j.bbih.2024.100927. eCollection 2025 Feb.
- Brankovic M, Gmizic T, Dukic M, Zdravkovic M, Daskalovic B, Mrda D, Nikolic N, Brajkovic M, Gojgic M, Lalatovic J, Kralj D, Pantic I, Vojnovic M, Milovanovic T, Durasevic S, Todorovic Z. Therapeutic Potential of Palmitoylethanolamide in Gastrointestinal Disorders. Antioxidants (Basel). 2024 May 14;13(5):600. doi: 10.3390/antiox13050600.
- Albanese M, Marrone G, Paolino A, Di Lauro M, Di Daniele F, Chiaramonte C, D'Agostini C, Romani A, Cavaliere A, Guerriero C, Magrini A, Mercuri NB, Di Daniele N, Noce A. Effects of Ultramicronized Palmitoylethanolamide (um-PEA) in COVID-19 Early Stages: A Case-Control Study. Pharmaceuticals (Basel). 2022 Feb 19;15(2):253. doi: 10.3390/ph15020253.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- PEA in Ulcerative colitis
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