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Palmitoylethanolamide in Ulcerative Colitis

ConditionUlcerative Colitis (UC)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnancy or breastfeeding.

Alcohol or drug abuse.

Allergy or known hypersensitivity to palmitoylethanolamide.

Active infection (enteric or systemic).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intervention groupActive comparator 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

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

Time frame
3 months

Secondary outcomes

1

Clinical remission

The percentage of patients who achieved clinical remission defined by a Simple Clinical Colitis Activity Index (SCCAI) score ≤ 2

Time frame
3 months
2

Change in disease activity

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)

Time frame
3 months
3

Serum C-reactive protein (CRP)

The change in serum C-reactive protein (CRP)

Time frame
3 months
4

Serum pentraxin-3 (PTX-3)

The change in serum pentraxin-3 (PTX-3)

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: