[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-celiac-wheat-sensitivity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-celiac-wheat-sensitivity":99},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100650607","liver-steatosis-and-fibrosis-in-non-celiac-wheat-sensitivity-patients-a-prospective-study-100650607",false,"NCT07750535","Liver Steatosis and Fibrosis in Non-Celiac Wheat Sensitivity Patients: a Prospective Study","Prevalence and Risk Factors of Liver Steatosis and Fibrosis in Non-Celiac Wheat Sensitivity Patients: a Prospective Study","The inclusion\u002Fexclusion criteria used to select the study population have been previously validated in other retrospective studies. Additional exclusion criteria related to steatosis and other liver diseases and specifically required for this study were adopted.\n\nInclusion criteria for Non-Celiac Wheat Sensitivity (NCWS) patients\n\n* age \\>18 and \\\u003C65 years;\n* subjects with wheat-dependent symptoms, both gastrointestinal and extra-intestinal;\n* negativity of IgA and IgG anti-deamidated gliadin peptide (DPG) antibodies, immunoglobulin (Ig)A and IgG anti-tissue transglutaminase (tTG) antibodies, and anti-endomysial antibodies (EMA);\n* absence of duodenal villous atrophy, documented in all patients carrying the human leukocyte antigen (HLA) DQ2 and\u002For DQ8 haplotypes (therefore regardless of the negativity of celiac disease (CeD)-specific serum antibodies), evaluated when the patients had consumed a minimum of 100g of pasta and\u002For bread a day, for at least 45 days;\n* absence of IgE-mediated wheat allergy (WA): negative skin prick-test and\u002For specific serum IgE assay for wheat, gluten and gliadin);\n* resolution of symptoms on a strict standard elimination diet (i.e. extended oligoantigenic, excluding wheat, cow's milk, egg, tomato and chocolate and other foods self-reported by the patient as causing symptoms), followed for at least 4 weeks, and the recurrence of the same symptoms after double-blind placebo-controlled challenge (DBPCC) with wheat (for further details see below);\n* complete medical records;\n* duration of follow-up longer than 12 months after initial diagnosis, with at least 2 outpatient visits during the follow-up period.\n\nInclusion criteria for Irritable Bowel Syndrome\u002FFunctional Dyspepsia (IBS\u002FFD) and other functional gastrointestinal disorders unrelated to NCWS or other food allergies\u002Fintolerances patients\n\n* age \\>18 and \\\u003C65 years;\n* subjects diagnosed with IBS\u002FFD and other functional gastrointestinal disorders, according to the Rome IV classification, 1 who did not specifically report symptoms\u002Fsigns, whether gastrointestinal or extra-intestinal, following ingestion of wheat or other foods and who did not respond to gluten-free diet (GFD).\n\nInclusion criteria for Celiac Disease (CeD) patients\n\n* age \\>18 and \\\u003C65 years;\n* subjects with gastrointestinal and extra-intestinal wheat-dependent symptoms that meet the diagnostic criteria of CeD 2: positivity of anti-tTG IgA and\u002For IgG antibodies and evidence of villous atrophy, according to the Marsh-Oberhuber classification, demonstrated by histology on duodenal biopsy;\n* clinical response to the GFD: resolution of gastrointestinal and\u002For extra-intestinal symptoms.\n\nExclusion criteria for all the patients enrolled in the study\n\n* self-exclusion of wheat from the diet and refusal to reintroduce it for diagnostic purposes, before entering the study;\n* drug abuse;\n* treatment with steroids and\u002For non-steroidal anti-inflammatory drugs in the 2 weeks before duodenal biopsy;\n* pregnancy or breastfeeding;\n* diagnosis of chronic inflammatory bowel disease or other organic pathologies affecting the digestive system (e.g., wheat allergy, microscopic colitis, diverticulitis, segmental colitis associated with diverticulosis, etc.), neurological diseases, major psychiatric disorders, infectious diseases, immunological deficiencies, and impairments limiting physical activity;\n* incomplete medical records;\n* lack of clinical follow-up for at least 12 months after diagnosis with \\>2 outpatient visits during the follow-up period.\n\nAdditional exclusion criteria related to liver steatosis and other liver diseases\n\n* absence of abdominal ultrasound (US) imaging performed before diagnosis (i.e. before starting the wheat-free\u002Fgluten-free diet in NCWS and CeD patients, and before any lifestyle modifications and\u002For drug\u002Fprebiotic\u002Fprobiotic intake in IBS\u002FFD patients);\n* incomplete clinical records, lacking the data considered for the present study;\n* chronic alcohol intake (\\>30 g\u002Fday for men and \\>20 g\u002Fday for women);\n* chronic hepatotropic virus infections \\[hepatitis B virus (HBV) and hepatitis C virus (HCV)\\];\n* autoimmune liver diseases;\n* congenital metabolic liver diseases (e.g. alpha-1 antitrypsin deficiency, hemochromatosis, Wilson's disease, porphyria, other storage diseases, etc.);\n* chronic long-term treatment with drugs associated with both macrovesicular (glucocorticoids, estrogens, tamoxifen, amiodarone, methotrexate, and 5-fluorouracil) and microvesicular (glucocorticoids, valproic acid, tetracycline, and zidovudine) steatosis.","ALL","18 Years","65 Years",{"count":20,"type":21},250,"ESTIMATED","OBSERVATIONAL","Hypothesizing an intestinal barrier impairment as a common pathophysiological substrate of both Non Celiac Wheat Sensitivity (NCWS) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MAFLD), in a retrospective cohort study (data not yet published), demographic, clinical, laboratory and histology data of NCWS patients at the time of diagnosis, were analyzed and compared to control subjects with Irritable Bowel Syndrome\u002FFunctional Dyspepsia (IBS\u002FFD) and freshly diagnosed Celiac Disease (CeD). NCWS diagnosis was performed by a double-blind placebo-controlled wheat challenge. Steatosis was confirmed by ultrasound examination. Our retrospective data showed that the frequency of liver of steatosis was lower in NCWS than in IBS patients. In addition, it seems that pre-diagnosis avoidance of wheat in NCWS correlates with protection from steatosis. A subset of NCWS patients, recently exposed to wheat, with clinical features suggesting increased IP, seems to be predisposed to liver steatosis and fibrosis.\n\nTo validate the results of the retrospective study, the researchers planned the present prospective study, to analyze the prevalence of liver steatosis and fibrosis, evaluated by ultrasound (US) examination, FibroScan analysis \\[CAP (Controlled Attenuation Parameter) and LSM (Liver Stiffness Measurement) values\\], FIB-4 (Fibrosis-4) index, and NFS \\[Non-alcoholic fatty liver disease (NAFLD) Fibrosis Score\\], in patients with NCWS at the time of diagnosis, comparing them with two control populations of newly diagnosed IBS\u002FFD and CeD patients.",[25,26,27,28,29],"Metabolic Dysfunction-Associated Steatotic Liver Disease","Non Celiac Wheat Sensitivity","Irritable Bowel Syndrome","Functional Dyspepsia","Celiac Disease",[31,32],"non-celiac wheat sensitivity","metabolic dysfunction-associated steatotic liver disease","RECRUITING","2026-08-06",{"date":36,"type":37},"2026-08-11","ACTUAL",{"date":39,"type":37},"2024-01-01",{"date":41,"type":21},"2030-12-31",{"name":43,"class":44},"University of Palermo","OTHER",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":45},"100639939","ncws-or-ibsfd-in-relatives-of-cd-patients-100639939","NCT07584473","NCWS or IBS\u002FFD in Relatives of CD Patients","Inclusion criteria\n\n* CD patient's relatives\n* \\>18 years old\n* reporting IBS\u002FFD-like and extraintestinal (EI) symptoms\n\nExclusion criteria\n\n* self-exclusion of wheat from the diet and refuse to reintroduce it for diagnostic purposes;\n* drug and\u002For alcohol (\\>30 g\u002Fday for men and \\>20 g\u002Fday for women) abuse;\n* treatment with steroids and\u002For non-steroidal anti-inflammatory drugs in the 2 weeks before duodenal biopsy;\n* pregnancy or breastfeeding;\n* diagnosis of chronic inflammatory bowel disease or other organic pathologies affecting the digestive system \\[e.g., IgE-mediated Wheat Allergy (WA), microscopic colitis, diverticulitis, segmental colitis associated with diverticulosis, etc.\\], neurological diseases, major psychiatric disorders, infectious diseases, immunological deficiencies, and impairments limiting physical activity.",{"count":53,"type":21},600,"INTERVENTIONAL",[56],"NA","Over 50% of non-celiac wheat sensitivity (NCWS) patients are HLA DQ2\u002FDQ8 positive and often have a Celiac Disease (CD) family history. Studies have identified a subgroup of NCWS patients whose clinical and immunological features are closer to CD than to irritable bowel syndrome\u002Ffunctional dyspepsia (IBS\u002FFD) ('inflammatory subgroup'). The investigators hypothesized that among CD patient's relatives, there might be a high number of NCWS subjects, who hypothetically belong to the 'inflammatory subgroup'. Therefore, the aim of this multi-step project is to identify the prevalence of both self-reported NCWS and IBS\u002FFD not related to wheat ingestion among CD patient's relatives (parents, grandparents, siblings and sons).",[26,59,28,29],"IBS (Irritable Bowel Syndrome)",[61,62,63,64,65],"non celiac wheat sensitivity","irritable bowel syndrome","functional dyspepsia","celiac disease","Relatives","2026-05-07",{"date":68,"type":37},"2026-05-13",{"date":70,"type":37},"2026-04-01",{"date":72,"type":21},"2028-04-30",{"name":43,"class":44},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":81,"targetDuration":4,"studyType":54,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":45},"100287676","response-to-different-wheat-genotypes-in-not-celiac-wheat-sensitivity-100287676","NCT03024775","Response to Different Wheat Genotypes in Not-celiac Wheat Sensitivity","Clinical Response and Cytokines Production After Challenge With Different Wheat Genotypes in Patients With Not-celiac Wheat Sensitivity.","Inclusion Criteria:\n\nAll the patients will meet the recently proposed criteria:\n\n* negative serum anti-tissue transglutaminase and antiendomysium (EmA) immunoglobulin (Ig)A and IgG antibodies\n* absence of intestinal villous atrophy\n* IgE-mediated immunoallergic tests negative to wheat (skin prick tests and\u002For serum specific IgE detection)\n* follow-up duration \\>12 months after the initial diagnosis\n* at least two outpatient visits during the follow-up period.\n\nAdjunctive criteria adopted in our patients will be:\n\n* resolution of the gastrointestinal symptoms on a standard elimination diet, without wheat, cow's milk, egg, tomato, chocolate, or other food(s) causing self-reported symptoms\n* symptom reappearance on DBPC wheat challenge, performed as described previously. As in previous studies, DBPC cow's milk protein challenge and other \"open\" food challenges will be also performed.\n\nExclusion Criteria:\n\nExclusion criteria will be:\n\n* age \\\u003C18 years\n* positive EmA in the culture medium of the duodenal biopsies, even if the villi to crypts ratio in the duodenal mucosa was normal\n* self-exclusion of wheat from the diet and refusal to reintroduce it before entering the study\n* other organic gastrointestinal diseases (i.e. careful exclusion of Crohn's disease)\n* concomitant treatment with steroids and\u002For antihistamines.",{"count":82,"type":21},50,[56],"Non-celiac gluten sensitivity (NCGS) is a condition where intestinal and extraintestinal symptoms are triggered by gluten ingestion in the absence of celiac disease and wheat allergy. Despite the great interest in NCGS, much remains unknown about the pathogenesis. Some studies seem to suggest that wheat components other than gluten (i.e. amylase\u002Ftrypsine inhibitors, ATIs) can cause the symptoms, and therefore the term \"non-celiac wheat sensitivity\" (NCWS) has been proposed instead of NCGS. It is believed that this condition is worldwide increasing, due to the evolution of wheat breeding (i.e. consumption of wheats with high gluten content), and that ancient wheats are better tolerated by NCWS patients than the modern ones. Therefore, the aim of the study is to determine whether the common belief regarding the fact that ancient wheats are better tolerated by NCWS patients than the modern ones is confirmed by scientific data, and to identify the wheat kernel components triggering this pathology. The availability of wheat materials with opposite characteristics, such as the period of development (ancient vs. modern), or the technological properties (cultivars with weak glutens vs. strong gluten), or the presence\u002Fabsence of specific ATIs polypeptides, will allow to define the role played by these factors. Therefore, the study has two objectives: 1) extraction and testing of total kernel proteins, in order to evaluate the inflammatory response to gluten and non-gluten proteins by peripheral blood mononuclear cells (PBMC) and immunocytes extracted by the rectal mucosa of NCWS patients and healthy control subjects, and 2) clinically testing two wheat genotypes, selected on the basis of the previous in vitro studies, showing the highest and the lowest in vitro inflammatory response, in order to verify their effect in triggering NCWS symptoms.",[86],"Non-celiac Wheat Sensitivity",[86,88,89,90],"ancient wheats","modern wheats","ATIs","2025-06-17",{"date":93,"type":37},"2025-06-22",{"date":95,"type":37},"2017-01-01",{"date":97,"type":21},"2026-12-01",{"name":43,"class":44},"Non-Celiac Wheat Sensitivity"]