[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488797":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":40,"locations":51,"responsibleParty":93,"collaborators":96,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":45,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":45,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":54,"whyStopped":45,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"University of Palermo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Open wheat challenge group","ACTIVE_COMPARATOR","Before starting the elimination diet (time 0, T0), intervention patients will be evaluated by experienced dermatologists, as well as by physicians with expertise in the field of food intolerance about GI and extraintestinal symptoms related to foods intake. Moreover, all these subjects will be subjected to blood, urine, and stools collections, and to a dietary consult, and a food and symptom's diary will be provided to all patients, which must be filled-in daily. After 2 months of elimination diet (time 1, T1), intervention patients will be evaluated again both clinically and by laboratory techniques, identically to T0. At this time-point, intervention patients will go to an open challenge, with reintroduction of wheat. After 2 weeks of open diet or whenever dermatologic, intestinal and\u002For extraintestinal symptoms should return or intensify (T2int), patients will be valued again both clinically and by laboratory techniques, identically to T0 and T1, and then will end the study.",[13],"Other: Open wheat challenge",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo group","PLACEBO_COMPARATOR","Before starting the elimination diet (time 0, T0), control patients will be evaluated by experienced dermatologists, as well as by physicians with expertise in food intolerance. Moreover, patients will be subjected to blood, urine, and stools collections, and to a dietary consult, and a food and symptom's diary will be provided. After 2 months of elimination diet (time 1, T1), patients will be evaluated, identically to T0. Then, control patients will be asked to repeat the elimination diet, this time removing wheat and all cow's milk products for further 2 months (T2con). Then, patients will be valued again both clinically and by laboratory techniques, identically to T0 and T1. Then, patients will go to an open challenge, with reintroduction of wheat. After 2 weeks of open diet or whenever dermatologic, intestinal and\u002For extraintestinal symptoms should return or intensify (T3con), patients will be valued again, identically to T0, T1 and T2con, and then will end the study.",[19],"Other: Placebo challenge",[21,27],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"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\u002For extraintestinal symptoms should return or intensify, all patients will be revaluated and will end the study.",[9],[26],"Wheat",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"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\u002For extraintestinal symptoms should return or intensify, all patients will be revaluated and will end the study.",[15],[32],"Placebo",[34,37],{"name":35,"affiliation":5,"role":36},"Antonio Carroccio, MD","STUDY_DIRECTOR",{"name":38,"affiliation":5,"role":39},"Maria R. Bongiorno, MD","STUDY_CHAIR",[41,47],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Pasquale Mansueto, MD","CONTACT","+393477279879",null,"pasquale.mansueto@unipa.it",{"name":48,"role":43,"phone":49,"phoneExt":45,"email":50},"Aurelio Seidita, MD","+393209150370","aurelio.seidita@unipa.it",[52,72,82],{"facility":53,"status":54,"city":55,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Dermatology Department of the University Hospital 'P. Giaccone' of Palermo, Italy,","RECRUITING","Palermo","90127","Italy","IT",{"type":60,"coordinates":61},"Point",[62,63],13.3636,38.1166,{"lat":63,"lon":62},[66,69],{"name":67,"role":43,"phone":45,"phoneExt":45,"email":68},"MARIA R. BONGIORNO, MD","mariarita.bongiorno@unipa.it",{"name":70,"role":43,"phone":45,"phoneExt":45,"email":71},"GIUSEPPE PISTONE, MD","giuseppe.pistone@unipa.it",{"facility":73,"status":54,"city":55,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":74,"geoPoint":76,"contacts":77},"Internal Medicine Department of the University Hospital of Palermo",{"type":60,"coordinates":75},[62,63],{"lat":63,"lon":62},[78,80],{"name":42,"role":43,"phone":79,"phoneExt":45,"email":46},"+39-091-6552884",{"name":42,"role":81,"phone":45,"phoneExt":45,"email":45},"PRINCIPAL_INVESTIGATOR",{"facility":83,"status":54,"city":55,"state":84,"zip":85,"country":57,"countryCode":58,"cosmosGeoPoint":86,"geoPoint":88,"contacts":89},"Internal Medicine Division of the \"Cervello-Villa Sofia\" Hospital","PA","90146",{"type":60,"coordinates":87},[62,63],{"lat":63,"lon":62},[90],{"name":35,"role":43,"phone":91,"phoneExt":45,"email":92},"+390916554815","acarroccio@hotmail.com",{"type":81,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"Pasquale Mansueto","Principal Investigator",[97],{"name":98,"class":99},"Aurelio Seidita","UNKNOWN","100488797","dietary-approach-to-mild-to-moderate-psoriasis-100488797",false,"NCT05644782","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","Inclusion criteria of psoriasis patients\n\n* age \\>18 and \\\u003C65 years;\n* no systemic therapy for psoriasis for at least 3 months before inclusion in the study;\n* 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);\n* absence of WA (negative prick-test and\u002For specific serum immunoglobulins (Ig)E assay for wheat, gluten, and gliadin).\n\nExclusion criteria of psoriasis patients age \\\u003C18 and \\>65 years;\n\n* severe chronic plaque-type psoriasis (based on BSA);\n* self-exclusion of gluten\u002Fwheat from the diet and refusal to reintroduce it, for diagnostic purposes, before entering the study;\n* pregnancy;\n* alcohol and\u002For drug abuse;\n* Helicobacter pylori and other bacterial and\u002For parasitic infections;\n* 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;\n* diagnosis of cancer\n* treatment with steroids and\u002For immunological therapies;\n* patients undergoing chemotherapy and\u002For radiotherapy.","ALL","18 Years","65 Years",{"count":111,"type":112},82,"ESTIMATED","INTERVENTIONAL",[115],"NA","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\u002Fwheat to increase intestinal permeability, it could be hypothesized that gluten\u002Fwheat 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.",[118,119],"Psoriasis","Gluten Sensitivity",[121,122,123],"psoriasis","gluten sensitivity","gluten-free diet","2026-01-08",{"date":126,"type":127},"2026-01-12","ACTUAL",{"date":129,"type":127},"2025-01-01",{"date":131,"type":112},"2027-01-01",{"name":5,"class":6},3]