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We aimed to verify whether fecal calprotectin (FCP), a marker of intestinal inflammation, could be used to confirm this inflammatory status and to test its diagnostic performance in differentiating NCWS from irritable bowel syndrome\/functional dyspepsia (IBS\/FD).\u00a0We conducted a multicenter study, comparing NCWS patients, diagnosed by a double-blind placebo-controlled wheat challenge, with IBS\/FD subjects. In the retrospective phase, FCP values were analyzed to define the prevalence of its positivity and its role as a NCWS diagnostic biomarker. In the prospective phase we tested the effects of a strict 6-month wheat-free diet (WFD) on FCP values.\u00a031.3% (<jats:italic>n<\/jats:italic>\u2009=\u200963\/201) of NCWS patients had above normal FCP values (NCWS FCP\u2009+), whereas all IBS\/FD patients proved negative (P\u2009=\u20090.0001). FCP using a cut-off value\u2009&gt;\u200941\u00a0\u00b5g\/g showed a 58.6% sensitivity and a 98.0% specificity (AUC 0.755, 95% C.I. 0.702\u20130.837) in distinguishing NCWS from IBS\/FD patients. Of the 63 NCWS FCP+, 65.1% had negative FCP values after\u2009\u2265\u20096\u00a0months of WFD, with a significant reduction in FCP values (<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.0001). All NCWS FCP- subjects still preserved negative FCP values after\u2009\u2265\u20096\u00a0months of WFD.\u00a0Our study showed that FCP can be a useful but supplementary diagnostic marker for differentiating between NCWS and IBS\/FD. Strict WFD adherence reduced FCP values, normalizing them in 65.1% of NCWS FCP\u2009+\u2009subjects. These data suggest the existence of two NCWS subgroups: NCWS FCP\u2009+\u2009characterized by a probable predominantly inflammatory\/immunologic pattern and NCWS FCP\u2212 featuring non-immuno-mediated etiopathogenetic mechanisms. (Registration number NCT01762579).<\/jats:p>","DOI":"10.1007\/s11739-024-03595-7","type":"journal-article","created":{"date-parts":[[2024,4,12]],"date-time":"2024-04-12T18:02:36Z","timestamp":1712944956000},"page":"1255-1266","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Fecal calprotectin levels in patients with non-celiac wheat sensitivity: a proof of concept"],"prefix":"10.1007","volume":"19","clinical-trial-number":[{"clinical-trial-number":"nct01762579","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Aurelio","family":"Seidita","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alessandra","family":"Giuliano","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maurizio","family":"Soresi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marta","family":"Chiavetta","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emilio","family":"Nardi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giuseppe","family":"Mogavero","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giulio","family":"Giannone","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8913-7916","authenticated-orcid":false,"given":"Antonio","family":"Carroccio","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pasquale","family":"Mansueto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,4,12]]},"reference":[{"issue":"1","key":"3595_CR1","doi-asserted-by":"publisher","first-page":"13","DOI":"10.1186\/1741-7015-10-13","volume":"10","author":"A Sapone","year":"2012","unstructured":"Sapone A, Bai JC, Ciacci C et al (2012) Spectrum of gluten-related disorders: consensus on new nomenclature and classification. 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