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

Luca Elli, Carolina Tomba, Federica Branchi, Leda Rosalba Roncoroni, Vincenza Lombardo, Maria Teresa Bardella, F. Ferretti, Dario Conte, Flavio Valiante, Lucia Fini, Edoardo Forti, Renato Cannizzaro, Stefania Maiero, Claudio Londoni, Adriano Lauri, G. Fornaciari, Nicoletta Lenoci, Rocco Spagnuolo, Guido Basilisco, Francesco SomalvicoBruno Borgatta, Gioacchino Leandro, Sergio Segato, Donatella Barisani, Gaetano Morreale, E. Buscarini

Research output: Contribution to journalArticle

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.

Original languageEnglish
Article number84
JournalNutrients
Volume8
Issue number2
DOIs
Publication statusPublished - Feb 8 2016

Fingerprint

Glutens
gluten
signs and symptoms (animals and humans)
placebos
Placebos
gluten-free diet
Gluten-Free Diet
Eating
relapse
ingestion
quality of life
Quality of Life
Recurrence
C-reactive protein
transaminases
endpoints
C-Reactive Protein
Cross-Over Studies
Iron
deterioration

Keywords

  • Double-blind placebo controlled challenge
  • Functional gastrointestinal disorders
  • Gluten-free diet
  • Irritable bowel syndrome
  • Non-celiac gluten sensitivity

ASJC Scopus subject areas

  • Food Science

Cite this

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. / Elli, Luca; Tomba, Carolina; Branchi, Federica; Roncoroni, Leda Rosalba; Lombardo, Vincenza; Bardella, Maria Teresa; Ferretti, F.; Conte, Dario; Valiante, Flavio; Fini, Lucia; Forti, Edoardo; Cannizzaro, Renato; Maiero, Stefania; Londoni, Claudio; Lauri, Adriano; Fornaciari, G.; Lenoci, Nicoletta; Spagnuolo, Rocco; Basilisco, Guido; Somalvico, Francesco; Borgatta, Bruno; Leandro, Gioacchino; Segato, Sergio; Barisani, Donatella; Morreale, Gaetano; Buscarini, E.

In: Nutrients, Vol. 8, No. 2, 84, 08.02.2016.

Research output: Contribution to journalArticle

Elli, L, Tomba, C, Branchi, F, Roncoroni, LR, Lombardo, V, Bardella, MT, Ferretti, F, Conte, D, Valiante, F, Fini, L, Forti, E, Cannizzaro, R, Maiero, S, Londoni, C, Lauri, A, Fornaciari, G, Lenoci, N, Spagnuolo, R, Basilisco, G, Somalvico, F, Borgatta, B, Leandro, G, Segato, S, Barisani, D, Morreale, G & Buscarini, E 2016, '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', Nutrients, vol. 8, no. 2, 84. https://doi.org/10.3390/nu8020084
Elli, Luca ; Tomba, Carolina ; Branchi, Federica ; Roncoroni, Leda Rosalba ; Lombardo, Vincenza ; Bardella, Maria Teresa ; Ferretti, F. ; Conte, Dario ; Valiante, Flavio ; Fini, Lucia ; Forti, Edoardo ; Cannizzaro, Renato ; Maiero, Stefania ; Londoni, Claudio ; Lauri, Adriano ; Fornaciari, G. ; Lenoci, Nicoletta ; Spagnuolo, Rocco ; Basilisco, Guido ; Somalvico, Francesco ; Borgatta, Bruno ; Leandro, Gioacchino ; Segato, Sergio ; Barisani, Donatella ; Morreale, Gaetano ; Buscarini, E. / 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. In: Nutrients. 2016 ; Vol. 8, No. 2.
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AU - Tomba, Carolina

AU - Branchi, Federica

AU - Roncoroni, Leda Rosalba

AU - Lombardo, Vincenza

AU - Bardella, Maria Teresa

AU - Ferretti, F.

AU - Conte, Dario

AU - Valiante, Flavio

AU - Fini, Lucia

AU - Forti, Edoardo

AU - Cannizzaro, Renato

AU - Maiero, Stefania

AU - Londoni, Claudio

AU - Lauri, Adriano

AU - Fornaciari, G.

AU - Lenoci, Nicoletta

AU - Spagnuolo, Rocco

AU - Basilisco, Guido

AU - Somalvico, Francesco

AU - Borgatta, Bruno

AU - Leandro, Gioacchino

AU - Segato, Sergio

AU - Barisani, Donatella

AU - Morreale, Gaetano

AU - Buscarini, E.

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