Journal
GUT
Volume 67, Issue 8, Pages 1410-1424Publisher
BMJ PUBLISHING GROUP
DOI: 10.1136/gutjnl-2017-314853
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Funding
- Swedish Research Council [522-2A09-195]
- Swedish Society of Medicine
- German Research Foundation (DFG)
- Ministry of Research and Development (BMBF)
- Leibniz Foundation
- Biocard
- Simtomax
- Academy of Finland
- Competitive Research Funding of the Tampere University Hospital
- Sigrid Juselius Foundation
- Hungarian Research Fund [NKFI 120392]
- Competitive State Research Financing of the Tampere University Hospital [9U038]
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Objective A gluten-free diet is the only treatment option of coeliac disease, but recently an increasing number of trials have begun to explore alternative treatment strategies. We aimed to review the literature on coeliac disease therapeutic trials and issue recommendations for outcome measures. Design Based on a literature review of 10 062 references, we (17 researchers and 2 patient representatives from 10 countries) reviewed the use and suitability of both clinical and non-clinical outcome measures. We then made expert-based recommendations for use of these outcomes in coeliac disease trials and identified areas where research is needed. Results We comment on the use of histology, serology, clinical outcome assessment (including patient-reported outcomes), quality of life and immunological tools including gluten immunogenic peptides for trials in coeliac disease. Conclusion C areful evaluation and reporting of outcome measures will increase transparency and comparability of coeliac disease therapeutic trials, and will benefit patients, healthcare and the pharmaceutical industry.
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