NCT05644782 Dietary Approach to Mild-to-moderate Psoriasis
| NCT ID | NCT05644782 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Palermo |
| Condition | Psoriasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 82 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 82 participants in total. It began in 2025-01-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion criteria of psoriasis patients * 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). Exclusion criteria of psoriasis patients age \<18 and \>65 years; * 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; * alcohol and/or drug abuse; * 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 * treatment with steroids and/or immunological therapies; * patients undergoing chemotherapy and/or radiotherapy.
Contact & Investigator
Antonio Carroccio, MD
STUDY DIRECTOR
University of Palermo
Frequently Asked Questions
Who can join the NCT05644782 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Psoriasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05644782 currently recruiting?
Yes, NCT05644782 is actively recruiting participants. Contact the research team at pasquale.mansueto@unipa.it for enrollment information.
Where is the NCT05644782 trial being conducted?
This trial is being conducted at Palermo, Italy, Palermo, Italy, Palermo, Italy.
Who is sponsoring the NCT05644782 clinical trial?
NCT05644782 is sponsored by University of Palermo. The principal investigator is Antonio Carroccio, MD at University of Palermo. The trial plans to enroll 82 participants.
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