NCT05644782

Dietary Approach to Mild-to-moderate Psoriasis

Recruiting now NA Last updated 12 January 2026

What this trial tests

NA trial testing Open wheat challenge in Psoriasis in 82 participants. Currently enrolling.

Timeline

1 January 2025

Primary endpoint
1 January 2026

1 January 2027

Quick facts

Lead sponsor	University of Palermo
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	82
Start date	1 January 2025
Primary completion	1 January 2026
Estimated completion	1 January 2027
Sites	3 locations across Italy

Drugs / interventions tested

• Open wheat challenge
• Placebo challenge

Conditions studied

• Psoriasis — all drugs for Psoriasis →
• Gluten Sensitivity — all drugs for Gluten Sensitivity →

Sponsor

University of Palermo

Who can join

Adults 18 to 65, any sex, with Psoriasis or Gluten Sensitivity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.