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.
Highlights
Non-celiac gluten sensitivity (NCGS) is a “syndrome characterized by intestinal and extra-intestinal symptoms related to the ingestion of gluten-containing food, in subjects that are not affected by either celiac disease (CD) or wheat allergy (WA)” [1,2,3]
The aim of our study was to identify patients with NCGS from those reporting an improvement of gastrointestinal symptoms after gluten-free diet (GFD) through a double-blind placebo-controlled gluten challenge with crossover
According to the enrollment criteria, 140 patients were included in the study but six interrupted their GFD regimen because of social commitments clashing with their GFD requirements
Summary
Non-celiac gluten sensitivity (NCGS) is a “syndrome characterized by intestinal and extra-intestinal symptoms related to the ingestion of gluten-containing food, in subjects that are not affected by either celiac disease (CD) or wheat allergy (WA)” [1,2,3]. Reports of patients presenting gluten-responsive clinical pictures in absence of CD have been published since the. The NCGS clinical picture is heterogeneous and not specific, including intestinal (diarrhea, constipation, bloating, nausea and epigastric pain) and extra-intestinal (lack of well-being, anxiety, tiredness, fibromyalgia, chronic fatigue, foggy mind and headache) symptoms [2]. The exclusion of CD or WA and a response to a gluten-free diet (GFD) are the main parameters used to identify this condition. A correct diagnosis is necessary to appropriately manage these patients and to avoid useless and costly diets
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