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Multicenter, randomized, double-blind, placebo-controlled clinical trial of vital wheat gluten oral immunotherapy
Wheat is a common food allergen that can cause anaphylaxis. We sought to determine the efficacy and safety of vital wheat gluten (VWG) oral immunotherapy (OIT). After baseline double-blind, placebo-controlled food challenge (DBPCFC), 46 patients with wheat allergy (median age, 8.7 years; range, 4.2-...
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Published in: | Journal of allergy and clinical immunology 2019-02, Vol.143 (2), p.651-661.e9 |
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Main Authors: | , , , , , , , |
Format: | Article |
Language: | English |
Subjects: | |
Citations: | Items that this one cites Items that cite this one |
Online Access: | Get full text |
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Summary: | Wheat is a common food allergen that can cause anaphylaxis.
We sought to determine the efficacy and safety of vital wheat gluten (VWG) oral immunotherapy (OIT).
After baseline double-blind, placebo-controlled food challenge (DBPCFC), 46 patients with wheat allergy (median age, 8.7 years; range, 4.2-22.3 years) were randomized 1:1 to low-dose VWG OIT or placebo, with biweekly escalation to 1445 mg of wheat protein (WP). After a year 1 DBPCFC, active subjects continued low-dose VWG OIT for another year and underwent a year 2 DBPCFC and, if passed, a subsequent off-therapy DBPCFC. Placebo-treated subjects crossed over to high-dose VWG OIT (maximum, 2748 mg of WP).
The median baseline successfully consumed dose (SCD) was 43 mg of WP in both groups. At year 1, 12 (52.2%) of 23 low-dose VWG OIT–treated and 0 (0%) of 23 placebo-treated subjects achieved the primary end point of an SCD of 4443 mg of WP or greater (P |
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ISSN: | 0091-6749 1097-6825 |
DOI: | 10.1016/j.jaci.2018.08.041 |