Navigation
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
This multicenter double-blind placebo-controlled trial published in 2016 involved placing participants with functional gastrointestinal symptoms on a 3-week gluten-free diet (GFD) before randomly assigning the responsive patients to gluten intake (5.6g per day) or placebo for 7 days, and subsequently switching the subjects into the other group (crossover). Symptoms and quality of life were monitored throughout by employing 10-cm VAS and SF36, while bodily analyses such as iron and C reactive protein were evaluated also. Of the 140 patients who enrolled for the study, 134 individuals (17 males) completed the first period. The primary endpoint set was the worsening of symptoms (VAS increase ≥3 cm) during gluten ingestion compared to placebo. Improvements in symptoms were reported by 101 subjects. Following the gluten challenge (that 98 participants underwent), 28 (all females) relapsed and suffered a deterioration in quality of life. Although no parameters were found to be statistically associated with positivity to the challenge, 14 patients responded to the placebo. This allowed the conclusion that around 14% may have non-celiac gluten sensitivity (symptoms appear after eating gluten-containing food) rather than coeliac disease. [NPIDs: gastrointestinal disorders, gluten, gluten-free, iron, C reactive protein, quality of life, gluten sensitivity, celiac, coeliac]
Year: 2016
