Healthy and pro-inflammatory gut ecology plays a crucial role in the digestion and tolerance of a novel Gluten Friendly™ bread in celiac subjects: Randomized, double blind, placebo control in vivo study

Angelo Andriulli, Antonio Bevilacqua, Orazio Palmieri, Anna Latiano, Rosanna Fontana, Domenica Gioffreda, Stefano Castellana, Tommaso Mazza, Anna Panza, Claudia Menzaghi, Elvira Grandone, Lazzaro di Mauro, Ivana Decina, Michele Tricarico, Daniela Musaico, Markku Mäki, Jorma Isola, Alina Popp, Juha Taavela, Leonardo PetruzziMilena Sinigaglia, Maria Rosaria Corbo, Carmela Lamacchia

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Abstract

Gluten Friendly™ (GF) is a new gluten achieved through a physicochemical process applied to wheat kernels. The goal of this research was to assess the in vivo effects of Gluten Friendly™ bread on celiac gut mucosa and microbiota. In a double-blind placebo-controlled intervention study, 48 celiac disease (CD) patients were randomized into 3 groups to eat 100 g of bread daily, containing different doses (0; 3 g; 6 g) of GF for 12 weeks. The small-bowel morphology (VH/CrD), intraepithelial densities of CD3+, celiac serology, MUC2, CB1, gut permeability, proinflammatory cytokines, gluten in stools, symptoms, and gut microbial composition were assessed. All 48 CD subjects experienced no symptoms. K-means analysis evidenced celiac subjects clustering around unknown parameters independent of GF dosage: K1 35%; K2 30%; K3 35%. VH/CrD significantly decreased in K1 and K2. VH/CrD did not correlate with IEL increase in K2. 33-mer was not detected in 47% and 73% of patients in both K1 and K2, respectively. VH/CrD and IEL did not change significantly and strongly correlated with the absence of 33-mer in K3. Inflammation and VH/CrD decrease are strongly related with the presence of proinflammatory species at the baseline. A boost in probiotic, butyrate-producing genera, is strongly related with GF tolerance at the end of the trial. Our research suggests that a healthy and proinflammatory ecology could play a crucial role in the digestion and tolerance of the new gluten molecule in celiac subjects. However, GF can be completely digested by gut microbiota of CD subjects and shapes it toward gut homeostasis by boosting healthy butyrate-producing populations. The clinical trial registry number is NCT03137862 (https://clinicaltrials.gov).
Original languageEnglish
Pages (from-to)1299-1315
Number of pages17
JournalFood and function
Volume13
Issue number3
DOIs
Publication statusPublished - 7 Feb 2022
Publication typeA1 Journal article-refereed

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