Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT05644782

Dietary Approach to Mild-to-moderate Psoriasis

Led by University of Palermo · Updated on 2026-01-12

82

Participants Needed

3

Research Sites

104 weeks

Total Duration

On this page

Sponsors

U

University of Palermo

Lead Sponsor

A

Aurelio Seidita

Collaborating Sponsor

AI-Summary

What this Trial Is About

Psoriasis is a systemic chronic inflammatory immune-mediated disease whose etiopathogenetic mechanisms involve genetic predisposition, and immunological and environmental factors. Its prevalence is about 3% in adults, and it is characterized by well-demarcated, erythematous plaques, covered by silvery-white scales, in elbows, knees, trunk, and scalp. However, psoriasis is far from being considered just a dermatologic condition because the cytokine's cascade, which lays behind its inflammatory and immune-mediated pathogenesis, can determine multiple systemic manifestations. In addition, several patients with psoriasis often complains of gastrointestinal (GI) symptoms. Therefore, authors focused their attention over the gut-skin axis and its possible pathogenetic and immunoregulatory role in psoriasis (i.e., altered gut barrier, increased blood concentration of gut microbiota-derived metabolites, systemic inflammation). In this context, several dietetic approaches (e.g., Mediterranean, low calories, protein-restricted, vegetarian diets, and gluten-free diet, GFD) have shown a certain efficacy in improve psoriasis cutaneous and systemic manifestations. In recent years, the existence of a wheat-related disorder in patients who do not suffer from CD or wheat allergy (WA) has been definitively ascertained and defined as Non-Celiac Wheat Sensitivity (NCWS). Its prevalence in the general population is unknown, but self-reported NCWS is around 10%. This condition is characterized by both GI and extraintestinal symptoms, which are triggered by wheat ingestion. In these patients, wheat ingestion might lead to alteration in intestinal permeability and gut microbiota and to systemic immune activation and inflammation. Based on the evidence of gut involvement in the pathogenesis and clinical manifestation of psoriasis, as well as on the ability of gluten/wheat to increase intestinal permeability, it could be hypothesized that gluten/wheat may represents one of the pathogenetic environmental factors of psoriasis and that its intake may be able to worsen symptoms in affected patients. The investigators hypothesize that a wheat-free diet (WFD) can reduce the inflammatory state and ameliorate the clinical symptoms in psoriasis patients. The successive clinical and immunologic reaction to the re-exposure to wheat ingestion, performed by an open challenge, will be also evaluated to confirm a wheat-dependent mechanism and to understand the underlining physiopathology.

CONDITIONS

Official Title

Dietary Approach to Mild-to-moderate Psoriasis

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age older than 18 and younger than 65 years
  • No systemic therapy for psoriasis for at least 3 months before joining the study
  • Negative blood tests for anti-deamidated gliadin protein (IgA and IgG), anti-tissue transglutaminase (IgA and IgG), and Endomysium antibodies
  • No wheat allergy as shown by negative prick-test and/or specific serum IgE for wheat, gluten, and gliadin
Not Eligible

You will not qualify if you...

  • Age younger than 18 or older than 65 years
  • Severe chronic plaque-type psoriasis based on body surface area
  • Self-exclusion of gluten/wheat from diet and refusal to reintroduce it before the study
  • Pregnancy
  • Alcohol or drug abuse
  • Helicobacter pylori or other bacterial/parasitic infections
  • Chronic inflammatory bowel disease or other serious digestive system diseases
  • Nervous system diseases, major psychiatric disorders, immune deficiencies, or physical activity limitations
  • Diagnosis of cancer
  • Treatment with steroids or immunological therapies
  • Undergoing chemotherapy or radiotherapy

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Dermatology Department of the University Hospital 'P. Giaccone' of Palermo, Italy,

Palermo, Palermo, Italy, 90127

Actively Recruiting

2

Internal Medicine Department of the University Hospital of Palermo

Palermo, Palermo, Italy, 90127

Actively Recruiting

3

Internal Medicine Division of the "Cervello-Villa Sofia" Hospital

Palermo, PA, Italy, 90146

Actively Recruiting

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Research Team

P

Pasquale Mansueto, MD

CONTACT

A

Aurelio Seidita, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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