Bauer, Jürgen M.
,
Mikušová, Lucia
Verlaan, Sjors
Bautmans, Ivan
Brandt, Kirsten
Donini, Lorenzo M.
Maggio, Marcello
Mets, Tony
Wijers, Sander L. J.
Garthoff, Jossie A.
Luiking, Yvette
Sieber, Cornel
Cederholm, Tommy
Funding for this research was provided by:
Nutricia Research Foundation
Article History
Received: 22 November 2019
Accepted: 17 February 2020
First Online: 12 March 2020
Compliance with ethical standards
:
: Jürgen Bauer is a scientific advisor and has received research grants and speakers honorarium from Nutricia and Nestlé. Lucia Mikušová, Sander Wijers and Yvette Luiking are employed by Danone Nutricia Research, Sjors Verlaan was an employee in the past and Jossie Garthoff works for Danone Food Safety Center. Tommy Cederholm has given remunerated lectures and has received unconditional research grants from Nutricia and Nestlé. Kirsten Brandt received a research grant from Nutricia Research during the conduct of the study. Ivan Bautmans, Tony Mets, Lorenzo M Donini, Marcello Maggio and Cornel Sieber declare that they have no conflict of interest.
: The study protocol was reviewed and approved by The Research Ethics Boards at each of the locations and was published and registered with the Dutch trials register with the identifier: NTR2329 (ExternalRef removed). Study procedures were performed in accordance with the Declaration of Helsinki ethical principles for medical research involving human subjects.
: All participants gave written informed consent prior to the RCT and volunteered to participate in the open-label extension of the study.