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Designing Trials for Testing the Efficacy of Pre- Pro- and Synbiotics

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Book cover Prebiotics and Probiotics Science and Technology

Abstract

Providing an evidence base for the rational delivery of medicines and treatments is the cornerstone of modern health care delivery. Much of this evidence base is gained through conducting clinical trials. Superficially, designing a clinical trial seems straightforward. However, in practice many unforeseen difficulties arise with long setting up times, poor recruitment rates and patients or interventions not behaving in the way expected. Unfortunately, clinical trials examining the efficacy of pre-, pro- and synbiotics have developed a reputation for being published in low impact journals and reaching unconvincing conclusions. As a generalization, the reason for this poor reputation is that the trials have tended to be too small and have not used meaningful clinical endpoints.

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Abbreviations

DBPC :

Double Blinded, Placebo Controlled

ICH-GCP :

International Conference for Harmonization of Good Clinical Practice

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© 2009 Springer Science+Business Media, LLC

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Lewis, S., Atkinson, C. (2009). Designing Trials for Testing the Efficacy of Pre- Pro- and Synbiotics. In: Charalampopoulos, D., Rastall, R.A. (eds) Prebiotics and Probiotics Science and Technology. Springer, New York, NY. https://doi.org/10.1007/978-0-387-79058-9_4

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