[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gluten-sensitivity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gluten-sensitivity":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100620825","single-cell-immune-response-to-controlled-gluten-ingestion-in-pediatric-celiac-disease-100620825",false,"NCT07362654","Single-cell Immune Response to Controlled Gluten Ingestion in Pediatric Celiac Disease","Single-cell Study of the Systemic Immune Response to Controlled Gluten Intake in Pediatric Celiac Disease","CELLiomicS","Inclusion Criteria:\n\n* Age 8 to 14 years at study entry.\n* Diagnosis of celiac disease according to ESPGHAN 2020 criteria.\n* At least 18 months on a strict gluten-free diet (GFD).\n* Adequate adherence to the GFD, demonstrated by negative fecal gluten immunogenic peptides (GIP) prior to inclusion.\n* Asymptomatic from a gastrointestinal perspective in the preceding weeks.\n* Ability to swallow the gluten\u002Fplacebo preparation.\n* Written informed consent from parents\u002Flegal guardians and assent from the child.\n\nExclusion Criteria:\n\n* Obesity defined as BMI ≥ 95th percentile according to WHO criteria.\n* Diagnosed inflammatory bowel disease or diabetes mellitus.\n* Acute infectious illness at the time of inclusion.\n* Chronic hepatic, pulmonary, renal, or rheumatologic disease.\n* History of severe acute reactions to accidental gluten ingestion.\n* Use of oral corticosteroids or immunosuppressive therapy in the previous 3 months.\n* Any condition that, in the opinion of the investigators, may contraindicate participation or compromise study integrity.","ALL","8 Years","14 Years",{"count":21,"type":22},51,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study investigates how the immune system of children with celiac disease responds to controlled, small amounts of gluten. Children on a strict gluten-free diet are randomly assigned to receive either placebo, 50 mg of gluten, or 5 g of gluten once daily for three days, simulating real-life accidental exposure or dietary transgression. Blood samples are collected on Day 1 (before gluten intake) and Day 8 (five days after the last dose). Stool and urine samples are also collected for complementary analyses.\n\nUsing single-cell ribonucleic acid (RNA) sequencing, T-cell receptor sequencing, microRNA profiling, and exploratory metabolomics, the study aims to characterize changes in immune cell populations and gene expression after gluten exposure. The objective is to determine whether even very small amounts of gluten induce measurable systemic immune responses and whether these responses differ according to the dose administered. Understanding these mechanisms may support the development of new biomarkers and improve clinical management of pediatric celiac disease.",[28,29,30],"Celiac Disease","Gluten Sensitivity","Autoimmune Diseases",[28,32,33,34,35,36,37],"Gluten Exposure","Single-Cell RNA Sequencing","Gluten-Free Diet","Immune Response","Pediatrics","Omics","RECRUITING","2026-04-22",{"date":41,"type":42},"2026-04-27","ACTUAL",{"date":44,"type":42},"2025-07-07",{"date":46,"type":22},"2026-11",{"name":48,"class":49},"Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":5},"100488797","dietary-approach-to-mild-to-moderate-psoriasis-100488797","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.","18 Years","65 Years",{"count":61,"type":22},82,[25],"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.",[65,29],"Psoriasis",[67,68,69],"psoriasis","gluten sensitivity","gluten-free diet","2026-01-08",{"date":72,"type":42},"2026-01-12",{"date":74,"type":42},"2025-01-01",{"date":76,"type":22},"2027-01-01",{"name":78,"class":49},"University of Palermo",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":17,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":92,"conditions":93,"keywords":99,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100455362","immune-responses-to-gluten-100455362","NCT05209568","Immune Responses to Gluten","Changes in Serum IL-2 Levels Following a Single Oral Dose of Gluten","Inclusion Criteria:\n\n1. On a gluten-free diet for ≥ 4 weeks\n2. Willing to consume gluten for research\n3. For the celiac disease arm, diagnosis confirmed by serology and\u002For histology\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Wheat allergy\n3. Type 1 diabetes\n4. BMI z-score \\\u003C -2\n5. History of more than minimal symptoms following gluten exposure on a gluten-free diet\n6. Comorbid condition that in the opinion of the investigator would interfere with study participation or would confound study results",true,"2 Years","101 Years",{"count":90,"type":22},400,[25],"This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.",[28,94,95,96,97,29,98],"Malabsorption Syndromes","Digestive System Disease","Intestinal Disease","Gastrointestinal Diseases","Celiac Disease in Children",[100,101,102],"gluten","cytokine","T cell immune response","2025-04-18",{"date":105,"type":42},"2025-04-23",{"date":107,"type":42},"2023-01-15",{"date":109,"type":22},"2029-09-30",{"name":111,"class":49},"Boston Children's Hospital",2]