Palmitoylethanolamide in Ulcerative Colitis

NCT07609810 | Not Yet Recruiting

• 1 other identifier: PEA in Ulcerative colitis
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ulcerative Colitis (UC)

Keywords

palmitoylethanolamide - endocannabinoid - disease activity

Outcome Measures

Primary Outcomes (1)

• Clinical response

  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

Secondary Outcomes (6)

• Clinical remission

  3 months

• Change in disease activity

  3 months

• Serum C-reactive protein (CRP)

  3 months

• Serum pentraxin-3 (PTX-3)

  3 months

• Fecal calprotectin (FCP)

  3 months

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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.

Dietary Supplement: Palmitoylethanolamide (PEA)

Control group

NO INTERVENTION

30 patients will receive their standard therapy according to the ECCO guidelines for 3 months. Standard therapy consists of: 5-Aminosalicylates, corticosteroids and azathioprine.

Interventions

Palmitoylethanolamide (PEA) DIETARY_SUPPLEMENT

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

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Internal Medicine and Gastroenterology clinic, El-Demerdash Hospital

Cairo, El-Abbasia, 11252, Egypt

Location

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Related Links

• Dynamedex Ulcerative colitis in adults webpage

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

palmidrol

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Ahmed Emad, Teaching Assistant

CONTACT

+201007546334; ahmed.emad18@pharma.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant in Clinical Pharmacy Department

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): February 15, 2029
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)