NCT07584473|Recruiting
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Sponsor study identifier
interventional
600
1 country
2
Study Start
April 1, 2026
Actual (reported)Primary Completion
April 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Over 50% of non-celiac wheat sensitivity (NCWS) patients are HLA DQ2/DQ8 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/functional dyspepsia (IBS/FD) ('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/FD not related to wheat ingestion among CD patient's relatives (parents, grandparents, siblings and sons).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2026
Actual (reported)April 25, 2026
Actual (reported)May 13, 2026
Actual (reported)April 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Identification of patients with self-reported NCWS or IBS/FD not related to wheat intake among relatives of CD patients: Gastrointestinal Symptom Rating Scale (GSRS)
CD patient's relatives included in the study will refill out the following online questionnaire at the end of the 6-week long strict WFD (T2): - Gastrointestinal Symptom Rating Scale (GSRS) (range from 15 to 105) Patients reporting a reduction ≥30% in the questionnaire after WFD will be identified as patients with self-reported NCWS. Patients not reporting a reduction ≥30% in at least one questionnaire after WFD will be identified as patients with IBS/FD not related to wheat intake.
From baseline to 6-week
Identification of patients with self-reported NCWS or IBS/FD not related to wheat intake among relatives of CD patients: Bristol Stool Scale
From baseline to 6-week
CD patient's first-degree relatives with IBS/FD-like and extraintestinal (EI) symptoms
Patients, identified at T1, will undergo a 6-week long strict WFD (preliminary dietician consul will be granted to all subjects), at the end of which (T2) they will fill-out an online form including a WFD adherence questionnaire (i.e. modified 'Biagi' score) and the questionnaires reported in WP1. Patients reporting a reduction ≥30% in at least one questionnaire after WFD will be identified as self-reported NCWS, all the others will be identified as IBS/FD not related to wheat intake.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Celiac Disease and Food Intolerance Clinic, Geriatrics Unit, "P. Giaccone" University Hospital, Palermo
Palermo, PA, 90127, Italy
Internal Medicine Unit, P.O. "V. Cervello," Ospedali Riuniti "Villa Sofia-Cervello," Palermo
Palermo, PA, 90146, Italy
Biagi F, Bianchi PI, Marchese A, Trotta L, Vattiato C, Balduzzi D, Brusco G, Andrealli A, Cisaro F, Astegiano M, Pellegrino S, Magazzu G, Klersy C, Corazza GR. A score that verifies adherence to a gluten-free diet: a cross-sectional, multicentre validation in real clinical life. Br J Nutr. 2012 Nov 28;108(10):1884-8. doi: 10.1017/S0007114511007367. Epub 2012 Feb 10.
Drossman DA, Hasler WL. Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction. Gastroenterology. 2016 May;150(6):1257-61. doi: 10.1053/j.gastro.2016.03.035. No abstract available.
Antonio Carroccio, MD
University of Palermo
First Submitted
April 25, 2026
First Posted
May 13, 2026
Study Start
April 1, 2026
Actual (reported)Primary Completion
April 30, 2027
EstimatedHydroxyapatite-Based Home Treatment for Dentin Sensitivity in Celiac Patients
Identification of patients with self-reported NCWS or IBS/FD not related to wheat intake among relatives of CD patients: IBS-Symptom Severity Scale (IBS-SSS)
From baseline to 6-week
Identification of patients with self-reported NCWS or IBS/FD not related to wheat intake among relatives of CD patients: Extraintestinal Symptom Rating Scale (ESRS)
From baseline to 6-week
Contact the study team to confirm eligibility.
Vaquero L, Rodriguez-Martin L, Alvarez-Cuenllas B, Hernando M, Iglesias-Blazquez C, Menendez-Arias C, Vivas S. Coeliac disease and gastrointestinal symptom screening in adult first-degree relatives. J Gastroenterol Hepatol. 2017 Dec;32(12):1931-1937. doi: 10.1111/jgh.13801.
Troncone R, Greco L, Mayer M, Mazzarella G, Maiuri L, Congia M, Frau F, De Virgiliis S, Auricchio S. In siblings of celiac children, rectal gluten challenge reveals gluten sensitization not restricted to celiac HLA. Gastroenterology. 1996 Aug;111(2):318-24. doi: 10.1053/gast.1996.v111.pm8690196.
Seidita A, Giuliano A, Soresi M, Chiavetta M, Nardi E, Mogavero G, Giannone G, Carroccio A, Mansueto P. Fecal calprotectin levels in patients with non-celiac wheat sensitivity: a proof of concept. Intern Emerg Med. 2024 Aug;19(5):1255-1266. doi: 10.1007/s11739-024-03595-7. Epub 2024 Apr 12.
Sapone A, Lammers KM, Casolaro V, Cammarota M, Giuliano MT, De Rosa M, Stefanile R, Mazzarella G, Tolone C, Russo MI, Esposito P, Ferraraccio F, Carteni M, Riegler G, de Magistris L, Fasano A. Divergence of gut permeability and mucosal immune gene expression in two gluten-associated conditions: celiac disease and gluten sensitivity. BMC Med. 2011 Mar 9;9:23. doi: 10.1186/1741-7015-9-23.
Mansueto P, Di Liberto D, Fayer F, Soresi M, Geraci G, Giannone AG, Seidita A, D'Alcamo A, La Blasca F, Lo Pizzo M, Florena AM, Dieli F, Carroccio A. TNF-alpha, IL-17, and IL-22 production in the rectal mucosa of nonceliac wheat sensitivity patients: role of adaptive immunity. Am J Physiol Gastrointest Liver Physiol. 2020 Sep 1;319(3):G281-G288. doi: 10.1152/ajpgi.00104.2020. Epub 2020 Jul 13.
Esteve M, Rosinach M, Fernandez-Banares F, Farre C, Salas A, Alsina M, Vilar P, Abad-Lacruz A, Forne M, Marine M, Santaolalla R, Espinos JC, Viver JM. Spectrum of gluten-sensitive enteropathy in first-degree relatives of patients with coeliac disease: clinical relevance of lymphocytic enteritis. Gut. 2006 Dec;55(12):1739-45. doi: 10.1136/gut.2006.095299. Epub 2006 May 18.
Di Liberto D, Mansueto P, D'Alcamo A, Lo Pizzo M, Lo Presti E, Geraci G, Fayer F, Guggino G, Iacono G, Dieli F, Carroccio A. Predominance of Type 1 Innate Lymphoid Cells in the Rectal Mucosa of Patients With Non-Celiac Wheat Sensitivity: Reversal After a Wheat-Free Diet. Clin Transl Gastroenterol. 2016 Jul 7;7(7):e178. doi: 10.1038/ctg.2016.35.
Carroccio A, Rini G, Mansueto P. Non-celiac wheat sensitivity is a more appropriate label than non-celiac gluten sensitivity. Gastroenterology. 2014 Jan;146(1):320-1. doi: 10.1053/j.gastro.2013.08.061. Epub 2013 Nov 22. No abstract available.
Carroccio A, Mansueto P, Iacono G, Soresi M, D'Alcamo A, Cavataio F, Brusca I, Florena AM, Ambrosiano G, Seidita A, Pirrone G, Rini GB. Non-celiac wheat sensitivity diagnosed by double-blind placebo-controlled challenge: exploring a new clinical entity. Am J Gastroenterol. 2012 Dec;107(12):1898-906; quiz 1907. doi: 10.1038/ajg.2012.236. Epub 2012 Jul 24.
Brottveit M, Beitnes AC, Tollefsen S, Bratlie JE, Jahnsen FL, Johansen FE, Sollid LM, Lundin KE. Mucosal cytokine response after short-term gluten challenge in celiac disease and non-celiac gluten sensitivity. Am J Gastroenterol. 2013 May;108(5):842-50. doi: 10.1038/ajg.2013.91. Epub 2013 Apr 16.
Araya M, Oyarzun A, Lucero Y, Espinosa N, Perez-Bravo F. DQ2, DQ7 and DQ8 Distribution and Clinical Manifestations in Celiac Cases and Their First-Degree Relatives. Nutrients. 2015 Jun 18;7(6):4955-65. doi: 10.3390/nu7064955.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 13, 2026
Record last verified: 2026-05
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