While a life-long gluten-free diet (GFD) is effective in most individuals with Celiac disease (CD), it is not effective in some. This could be related to cross contamination of food products, improper/inaccurate labeling and perhaps other factors as well. As a consequence, there is a rationale for the development of medical therapy. A recent study (Gastroenterol 2014; 146: 1649-58) has shown the ability of ALV003, a mixture of 2 recombinant gluten-specific proteases administered orally, to protect patients with celiac disease from gluten-induced mucosal injury in a phase 2 trial.
Methods: In a 6-week challenge study, adults with biopsy-proven celiac disease were divided into a treatment group with ALV003 (n=20) or a placebo group (n=21). The 2.0 g gluten dose (equivalent to 1/2 slice of bread) for the study was determined after an optimization study (using 1.5 g, 3.0 g or 6.0 g of gluten (bread crumbs) in three divided doses). Biopsies were taken before and after the gluten challenge.
- No significant mucosal deterioration was observed in biopsies from the ALV003 group based on biopsies after the challenge period. In contrast, the placebo group did have evidence of mucosal injury.
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