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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

OTHER

Open wheat challenge

Patients randomized to intervention diet group will have to follow a diet with elimination of wheat and cow's milk products for 2 months; after that they will be exposed to an open wheat challenge, with reintroduction of wheat. After 2 weeks of open diet, or whenever dermatologic, intestinal and/or extraintestinal symptoms should return or intensify, all patients will be revaluated and will end the study.

OTHER

Placebo challenge

Patients randomized to control diet group will have to follow a diet with elimination of rice and turkey's meat products for 2 months; after that they will crossover to a wheat and cow's milk products free diet and, finally, after 2 months, they will be exposed to an open wheat challenge, with reintroduction of wheat. After 2 weeks of open diet, or whenever dermatologic, intestinal and/or extraintestinal symptoms should return or intensify, all patients will be revaluated and will end the study.

Locations (3)

Dermatology Department of the University Hospital 'P. Giaccone' of Palermo, Italy,
Palermo, Palermo, Italy
Internal Medicine Department of the University Hospital of Palermo
Palermo, Palermo, Italy
Internal Medicine Division of the "Cervello-Villa Sofia" Hospital
Palermo, PA, Italy