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

被引:133
作者
Elli, Luca [1 ]
Tomba, Carolina [1 ,2 ]
Branchi, Federica [1 ,2 ]
Roncoroni, Leda [1 ,2 ,3 ]
Lombardo, Vincenza [1 ]
Bardella, Maria Teresa [1 ]
Ferretti, Francesca [1 ,2 ]
Conte, Dario [1 ,2 ]
Valiante, Flavio [4 ]
Fini, Lucia [5 ]
Forti, Edoardo [6 ]
Cannizzaro, Renato [7 ]
Maiero, Stefania [7 ]
Londoni, Claudio [8 ]
Lauri, Adriano [9 ]
Fornaciari, Giovanni [10 ]
Lenoci, Nicoletta [11 ]
Spagnuolo, Rocco [12 ]
Basilisco, Guido [13 ]
Somalvico, Francesco [14 ]
Borgatta, Bruno [15 ]
Leandro, Gioacchino [16 ]
Segato, Sergio [17 ]
Barisani, Donatella [18 ]
Morreale, Gaetano [19 ]
Buscarini, Elisabetta [8 ]
机构
[1] Fdn IRCCS Ca Granda Osped Maggiore Policlin, Ctr Prevent & Diag Celiac Dis, Gastroenterol & Endoscopy Unit, Via Francesco Sforza 35, I-20122 Milan, Italy
[2] Univ Milan, Dept Med Surg & Transplant Physiopathol, Via Francesco Sforza 35, I-20122 Milan, Italy
[3] Univ Milan, Dept Biomed Surg & Dent Sci, Via Festa Perdono 7, I-20122 Milan, Italy
[4] Santa Maria del Prato Hosp, Gastroenterol & Digest Endoscopy Unit, Via Bagnols Sur Ceze 1, I-32032 Feltre, Italy
[5] Busto Arsizio Hosp, Dept Internal Med, Gastroenterol & Digest Endoscopy Unit, Via A Da Brescia 1, I-21052 Busto Arsizio, Italy
[6] Osped Niguarda Ca Granda, Operat Endoscopy Unit, Piazza Osped Maggiore 3, I-20162 Milan, Italy
[7] CRO Natl Canc Inst, Gastroenterol, Via Franco Gallini 2, I-33081 Aviano, Italy
[8] Crema Maggiore Hosp, Gastroenterol & Endoscopy Unit, Largo Dossena 2, I-26013 Crema, Italy
[9] Osped Civile Santo Spirito, Gastroenterol Unit, Via Fonte Romana 8, I-65100 Pescara, Italy
[10] IRCCS Arcispedale S Maria Nuova, Med & Gastroenterol Unit, Via Risorgimento 80, I-42100 Reggio Emilia, Italy
[11] Osped Valduce, Gastroenterol Unit, Via Dante Alighieri 11, I-22100 Como, Italy
[12] Magna Graecia Univ Catanzaro, Dept Expt & Clin Med, I-88100 Catanzaro, Italy
[13] Fdn IRCCS Ca Granda Osped Maggiore Policlin, Gastroenterol & Endoscopy Unit, Via Francesco Sforza 35, I-20122 Milan, Italy
[14] Alphasearch, Via Gianfrancesco Parravicini, I-20900 Monza, Italy
[15] Osped San Biagio, Med Unit, Piazza Vittime Lager Nazifascisti 1, I-28845 Domodossola, Italy
[16] IRCCS De Bellis Hosp, Dept Gastroenterol, SP Turi 27, I-70013 Castellana Grotte, BA, Italy
[17] Macchi Hosp Varese, Gastroenterol & GI Endoscopy Unit, Viale Luigi Borri 57, I-21100 Varese, Italy
[18] Univ Milano Bicocca, Sch Med & Surg, Via Cadore 48, I-20900 Monza, Italy
[19] Policlin Palermo, Gastroenterol Unit, Via Vespro 129, I-90127 Palermo, Italy
关键词
non-celiac gluten sensitivity; gluten-free diet; double-blind placebo controlled challenge; functional gastrointestinal disorders; irritable bowel syndrome; WHEAT SENSITIVITY; DISEASE;
D O I
10.3390/nu8020084
中图分类号
R15 [营养卫生、食品卫生]; TS201 [基础科学];
学科分类号
100403 ;
摘要
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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