Outcome measures in coeliac disease trials: The Tampere recommendations

Jonas F. Ludvigsson, Carolina Ciacci, Peter H.R. Green, Katri Kaukinen, Ilma R. Korponay-Szabo, Kalle Kurppa, Joseph A. Murray, Knut Erik Aslaksen Lundin, Markku J. Maki, Alina Popp, Norelle R. Reilly, Alfonso Rodriguez-Herrera, David S. Sanders, Detlef Schuppan, Sarah Sleet, Juha Taavela, Kristin Voorhees, Marjorie M. Walker, Daniel A. Leffler

Research output: Contribution to journalArticle

29 Scopus citations

Abstract

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 Careful 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.

Original languageEnglish (US)
Pages (from-to)1410-1424
Number of pages15
JournalGut
Volume67
Issue number8
DOIs
StatePublished - Aug 1 2018

Keywords

  • celiac disease
  • clinical trials
  • gluten
  • gluten free diet

ASJC Scopus subject areas

  • Gastroenterology

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    Ludvigsson, J. F., Ciacci, C., Green, P. H. R., Kaukinen, K., Korponay-Szabo, I. R., Kurppa, K., Murray, J. A., Lundin, K. E. A., Maki, M. J., Popp, A., Reilly, N. R., Rodriguez-Herrera, A., Sanders, D. S., Schuppan, D., Sleet, S., Taavela, J., Voorhees, K., Walker, M. M., & Leffler, D. A. (2018). Outcome measures in coeliac disease trials: The Tampere recommendations. Gut, 67(8), 1410-1424. https://doi.org/10.1136/gutjnl-2017-314853