Accepted for Publication: February 8, 2012.
Author Contributions: Drs Beerepoot, van der Wal, and ter Riet had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Beerepoot, ter Riet, Nys, de Reijke, Prins, Verbon, Stobberingh, and Geerlings. Acquisition of data: Beerepoot, Nys, de Borgie, de Reijke, Koeijers, Stobberingh, and Geerlings. Analysis and interpretation of data: Beerepoot, ter Riet, van der Wal, Prins, and Geerlings. Drafting of the manuscript: Beerepoot, van der Wal, de Borgie, and Geerlings. Critical revision of the manuscript for important intellectual content: ter Riet, Nys, van der Wal, de Reijke, Prins, Koeijers, Verbon, Stobberingh, and Geerlings. Statistical analysis: Beerepoot, ter Riet, and van der Wal. Obtained funding: ter Riet, Stobberingh, and Geerlings. Administrative, technical, and material support: Beerepoot, Nys, Koeijers, and Stobberingh. Study supervision: ter Riet, Nys, de Borgie, de Reijke, Prins, Verbon, and Geerlings.
Financial Disclosure: None reported.
Funding/Support: Placebo capsules (not the active substances) were kindly donated by Chr Hansen A/S, Denmark. This work was supported by grant 62000017 from the Netherlands Organization for Health Research and Development.
Previous Presentations: This study was presented as a poster during the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy/Infectious Diseases Society of America Meeting; September 14, 2009; San Francisco, California.
Additional Contributions: We are very grateful to all the patients who participated in this trial. C. Driessen, MSc, J. Maes, BS, A. Zeelen, BS, and C. van den Bogaerd, BS, from the microbiology laboratory of the Maastricht University Medical Centre performed the microbiologic assays (the laboratory was financially compensated); A. Vyth, MSc, and W. Veenstra from the central pharmacy in the Academic Medical Center prepared the coded drug packs (the pharmacy was financially compensated); M. Roskam-Mul, MSc, and J. Mohrs helped with data management; and medical students K. Slootmaker, MD, L. Pijnenburg, MD, H. Struijk, MD, R. Britstra, MD, and J. Langeraar, MD, assisted during recruitment, inclusion, and data entry. Members of the Data and Safety Monitoring Board were J. Veenstra, MD, PhD; R. van Etten, MD, PhD; K. Brinkman, MD, PhD; K. Schurink, MD, PhD; M. Soesan, MD; S. van der Geest, MD, PhD; and W. Geraedts, MD, PhD. We would also like to thank the 10 Dutch participating hospitals (and the local study coordinators): Academic Medical Center in Amsterdam (S. E. de Rooij, MD, PhD), Maastricht University Medical Center (J. Koeijers, MD, PhD), University Medical Center in Utrecht (I. M. Hoepelman, MD, PhD), Medical Center Alkmaar (S. D. Bos, MD, PhD), Onze Lieve Vrouwe Gasthuis in Amsterdam (G. van Andel, MD, PhD), Sint Lucas Andreas Hospital in Amsterdam (E. van Haarst, MD), Slotervaart Hospital in Amsterdam (J. P. C. M. van Campen, MD), Scheper Hospital in Emmen (W. van der Hoek, MD), Haga Hospital in Den Haag (F. Froehling, MD), and Orbis Medical Center in Sittard (J. V. Zambon, MD, PhD). Antibiotic prophylaxis and placebo tablets were prepared by Tiofarma BV, Oud-Beijerland, the Netherlands.
Additional Information: Dr Gregor Reid held patents for L rhamnosus GR-1 and L reuteri RC-14 but has transferred the rights to Chr Hansen A/S, Denmark.