NCT05644782Recruiting
Dietary Approach to Mild-to-moderate Psoriasis
The Role of Gut-skin Axis in Psoriasis: a Randomized Placebo-controlled Dietary Approach to Assess Clinical Efficacy in Mild-to-moderate Psoriasis
Source: ClinicalTrials.gov · Last updated 12 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 82 (estimated)
- First submitted
- 27 Oct 2022
- Start date
- 1 Jan 2025
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- University of Palermo
- Diseases
- Psoriasis
- NCT number
- NCT05644782
What you commit to
- Study type: Interventional
- Planned participants: 82
- From 1 Jan 2025 to the primary completion date, 1 Jan 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- alcohol and/or drug abuse;
- treatment with steroids and/or immunological therapies;
- patients undergoing chemotherapy and/or radiotherapy.
Other illness
- Helicobacter pylori and other bacterial and/or parasitic infections;
- diagnosis of chronic inflammatory bowel disease and other organic pathology affecting the digestive system (e.g., severe liver disease), nervous system diseases, major psychiatric disorders, immunological deficits, and impairments that limit physical activity;
- diagnosis of cancer
Other
- severe chronic plaque-type psoriasis (based on BSA);
- self-exclusion of gluten/wheat from the diet and refusal to reintroduce it, for diagnostic purposes, before entering the study;
- pregnancy;
Who the study is looking for
- age \>18 and \<65 years;
- no systemic therapy for psoriasis for at least 3 months before inclusion in the study;
- negativity of anti-deamidated gliadin protein (anti-DGP) immunoglobulins (Ig) class A (IgA) and immunoglobulins (Ig)G, anti-tissue transglutaminase (anti-tTG) class IgA and IgG, and Endomysium antibodies (EmA);
- absence of WA (negative prick-test and/or specific serum immunoglobulins (Ig)E assay for wheat, gluten, and gliadin).
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Internal Medicine Division of the "Cervello-Villa Sofia" Hospital Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
| Dermatology Department of the University Hospital 'P. Giaccone' of Palermo, Italy, Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
| Internal Medicine Department of the University Hospital of Palermo Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.