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Dietary Approach to Mild-to-moderate Psoriasis

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Jul 30, 2024 to Jan 1, 2026v5 Show 4 more changesShow less
    • Start date: Jan 1, 2023 to Jan 1, 2025
    • Study completion date: Oct 31, 2025 to Jan 1, 2027
    • Site contacts updated at 1 of 3 sites
    • Publications: details revised at 5 of 5 entries
  2. Minor Study completion date: Oct 31, 2024 to Oct 31, 2025
    • Site details revised at 2 of 3 sites
    • Publications: details revised at 5 of 5 entries
    v4
  3. Notable Primary completion date: Jul 30, 2023 to Jul 30, 2024
    • Study completion date: Dec 31, 2023 to Oct 31, 2024
    v3
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Jun 30, 2023 to Jul 30, 2023
    • Start date changed from estimate of Dec 1, 2022 to Jan 1, 2023
    • Site details revised at 3 of 3 sites
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05644782
Lead Sponsor University of Palermo
Collaborators: Aurelio Seidita
Conditions
(from sponsor)
Psoriasis, Gluten Sensitivity
Related terms Celiac Disease, Psoriasis
Enrollment 82 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov