Smeets, Xavier J. N. M.
,
da Costa, David W.
Fockens, Paul
Mulder, Chris J. J.
Timmer, Robin
Kievit, Wietske
Zegers, Marieke
Bruno, Marco J.
Besselink, Marc G. H.
Vleggaar, Frank P.
van der Hulst, Rene W. M.
Poen, Alexander C.
Heine, Gerbrand D. N.
Venneman, Niels G.
Kolkman, Jeroen J.
Baak, Lubbertus C.
Römkens, Tessa E. H.
van Dijk, Sven M.
Hallensleben, Nora D. L.
van de Vrie, Wim
Seerden, Tom C. J.
Tan, Adriaan C. I. T. L.
Voorburg, Annet M. C. J.
Poley, Jan-Werner
Witteman, Ben J.
Bhalla, Abha
Hadithi, Muhammed
Thijs, Willem J.
Schwartz, Matthijs P.
Vrolijk, Jan Maarten
Verdonk, Robert C.
van Delft, Foke
Keulemans, Yolande
van Goor, Harry
Drenth, Joost P. H.
van Geenen, Erwin J. M.
Funding for this research was provided by:
ZonMw (837001506)
Article History
Received: 2 January 2018
Accepted: 6 March 2018
First Online: 2 April 2018
Authors’ information
: Coordinating center, primary sponsor, and principal investigatorsRadboud University Medical Centre, Nijmegen, The Netherlands; E. van Geenen, MD PhD & J. Drenth, MD PhD, Department of Gastroenterology.CorrespondenceE. van Geenen, MD PhD, Department of Gastroenterology, Radboud University Medical Centre, Nijmegen.Email: erwin.vangeenen@radboudumc.nlTelephone number: + 31 24361 1111.Steering committeeProject committeeUnorderedList removedApart from the researchers above, the following persons substantially contributed to the protocol:UnorderedList removedEndpoint adjudication committeeThe blinded endpoint adjudication committee consists of six gastroenterologists, one radiologist and one nephrologist:UnorderedList removedData safety monitoring boardUnorderedList removedParticipating centers and principal investigatorsOrderedList removedIndependent expertsUnorderedList removedKey staffUnorderedList removed
: The FLUYT trial will be performed in accordance with the declaration of Helsinki and the Dutch Medical Research Involving Human Subjects Act (WMO). Informed consent will be obtained from each patient before inclusion in the trial. The medical ethics committee of the St. Antonius Hospital in the Netherlands (Medical Research Ethics Committees United; MEC-U; code 100) approved the study protocol on the 14th of April 2015 (registration number R15.008). As the FLUYT trial investigates a medicinal product, the competent authority (Central Committee on Research Involving Human Subjects; CCMO; code 000) carried out a marginal assessment and approved the study on May 6, 2015. Finally, local board approval will be obtained in all participating centres before patients are included.
: Not applicable.
: The authors declare that they have no competing interests.
: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.