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Evidence for the Presence of Non-Celiac Gluten Sensitivity in Patients with Functional Gastrointestinal Symptoms: Results from a Multicenter Randomized Double-Blind Placebo-Controlled Gluten Challenge.

Center for the Prevention and Diagnosis of Celiac Disease, Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, via Francesco Sforza 35, 20122 Milano, Italy. lucelli@yahoo.com. Center for the Prevention and Diagnosis of Celiac Disease, Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, via Francesco Sforza 35, 20122 Milano, Italy. tomba.carolina@gmail.com. Department of Medical, Surgical and Transplant Physiopathology, University of Milan, via Francesco Sforza 35, 20122 Milan, Italy. tomba.carolina@gmail.com. Center for the Prevention and Diagnosis of Celiac Disease, Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, via Francesco Sforza 35, 20122 Milano, Italy. federica.branchi@gmail.com. Department of Medical, Surgical and Transplant Physiopathology, University of Milan, via Francesco Sforza 35, 20122 Milan, Italy. federica.branchi@gmail.com. Center for the Prevention and Diagnosis of Celiac Disease, Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, via Francesco Sforza 35, 20122 Milano, Italy. leda.roncoroni@tiscali.it. Department of Medical, Surgical and Transplant Physiopathology, University of Milan, via Francesco Sforza 35, 20122 Milan, Italy. leda.roncoroni@tiscali.it. Department of Biomedical, Surgical and Dental Sciences, University of Milan, via Festa del Perdono 7, 20122 Milan, Italy. leda.roncoroni@tiscali.it. Center for the Prevention and Diagnosis of Celiac Disease, Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, via Francesco Sforza 35, 20122 Milano, Italy. vicky.l@hotmail.com. Center for the Prevention and Diagnosis of Celiac Disease, Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, via Francesco Sforza 35, 20122 Milano, Italy. mariateresa.bardella@yahoo.com. Center for the Prevention and Diagnosis of Celiac Disease, Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, via Francesco Sforza 35, 20122 Milano, Italy. francesca.ferretti01@gmail.com. Department of Medical, Surgical and Transplant Physiopathology, University of Milan, via Francesco Sforza 35, 20122 Milan, Italy. francesca.ferretti01@gmail.com. Center for the Prevention and Diagnosis of Celiac Disease, Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, via Francesco Sforza 35, 20122 Milano, Italy. dario.conte@unimi.it. Department of Medical, Surgical and Transplant Physiopathology, University of Milan, via Francesco Sforza 35, 20122 Milan, Italy. dario.conte@unimi.it. Gastroenterology and Digestive Endoscopy Unit, Santa Maria del Prato Hospital, via Bagnols sur Ceze 1, 32032 Feltre, Italy. flavio.valiante@gmail.com. Department of Internal Medicine, Gastroenterology and Digestive Endoscopy Unit, Busto Arsizio Hospital, via A. Da Brescia 1, 21052 Busto Arsizio, Italy. finilucia@yahoo.it. Operative Endoscopy Unit, Niguarda Ca' Granda Hospital, Piazza Ospedale Maggiore 3, 20162 Milan, Italy. edoardo.forti@ospedaleniguarda.it. Gastroenterology, CRO National Cancer Institute, via Franco Gallini 2, 33081 Aviano, Italy. rcannizzaro@cro.it. Gastroenterology, CRO National Cancer Institute, via Franco Gallini 2, 33081 Aviano, Italy. smaiero@cro.it. Gastroenterology and Endoscopy Unit, Crema Maggiore Hospital, Largo Dossena 2, 26013 Crema, Italy. c.londoni@hcrema.it. Gastroenterology Unit, Ospedale Civile Santo Spirito, via Fonte Romana 8, 65100 Pescara, Italy. adriano.lauri@tin.it. Medicine and Gastroenterology Unit, IRCCS Arcispedale S. Maria Nuova, via Risorgimento 80, 42100 Reggio Emilia, Italy. Giovanni.Fornaciari@asmn.re.it. Gastroenterology Unit, Ospedale Valduce, via Dante Alighieri 11, 22100 Como, Italy. nicolettalenoci@libero.it. Department of Experimental and Clinical Medicine, Magna Græcia University, Loc. Germaneto, 88100 Catanzaro, Italy. rocco.spagnuolo79@gmail.com. Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, via Francesco Sforza 35, 20122 Milano, Italy. basilisc@policlinico.mi.it. Alphasearch, via Gianfrancesco Parravicini 40, 20900 Monza, Italy. flavio.valiante@gmail.com. Medicine Unit, Ospedale San Biagio, Piazza Vittime dei Lager Nazifascisti 1, 28845 Domodossola, Italy. borgattabruno@alice.it. Gastroenterological Department, IRCCS "De Bellis" Hospital, SP Turi 27, 70013 Castellana Grotte (BA), Italy. leandro@media.it. Gastroenterology and GI Endoscopy Unit, Macchi Hospital-Varese, Viale Luigi Borri 57, 21100 Varese, Italy. sergio.segato@katamail.com. School of Medicine and Surgery, University of Milano-Bicocca, via Cadore 48, 20900 Monza, Italy. donatella.barisani@unimib.it. Gastroenterology Unit, Policlinico of Palermo, via del Vespro 129, 90127 Palermo, Italy. gaetanocmorreale@libero.it. Gastroenterology and Endoscopy Unit, Crema Maggiore Hospital, Largo Dossena 2, 26013 Crema, Italy. ebuscarini@rim.it.

Nutrients. 2016;(2):84
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Abstract

Non-celiac gluten sensitivity (NCGS) is characterized by the onset of symptoms after eating gluten-containing food. We aimed to single out NCGS subjects among subjects with functional gastrointestinal symptoms. Patients were enrolled in a multicenter double-blind placebo-controlled trial with crossover. Symptoms and quality of life were evaluated by means of 10-cm VAS and SF36. Iron parameters, transaminases and C reactive protein (CRP) were evaluated. After a three-week-long gluten-free diet (GFD), responsive patients were randomly assigned to gluten intake (5.6 g/day) or placebo for seven days, followed by crossover. The primary endpoint was the worsening of symptoms (VAS increase ≥3 cm) during gluten ingestion compared to placebo. One hundred and forty patients were enrolled and 134 (17 males, mean age 39.1 ± 11.7 years, BMI 22.4 ± 3.8) completed the first period. A total of 101 subjects (10 males, mean age 39.3 ± 11.0 years, BMI 22.3 ± 4.0) reported a symptomatic improvement (VAS score 2.3 ± 1.2 vs. 6.5 ± 2.2 before and after GFD, p = 0.001). 98 patients underwent the gluten challenge and 28 (all females, mean age 38.9 ± 12.7 years, BMI 22.0 ± 2.9) reported a symptomatic relapse and deterioration of quality of life. No parameters were found to be statistically associated with positivity to the challenge. However, 14 patients responded to the placebo ingestion. Taking into account this finding, about 14% of patients responding to gluten withdrawal showed a symptomatic relapse during the gluten challenge. This group is suspected to have NCGS.

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MeSH terms : Glutens