A randomized, double-blind, controlled study and pooled analysis of two identical trials of fermented milk containing probiotic Bifidobacterium lactis CNCM I-2494 in healthy women reporting minor digestive symptoms
Article first published online: 11 MAR 2013
© 2013 Blackwell Publishing Ltd
Neurogastroenterology & Motility
Volume 25, Issue 4, pages 331–e252, April 2013
How to Cite
Marteau, P., Guyonnet, D., Lafaye de Micheaux, P. and Gelu, S. (2013), A randomized, double-blind, controlled study and pooled analysis of two identical trials of fermented milk containing probiotic Bifidobacterium lactis CNCM I-2494 in healthy women reporting minor digestive symptoms. Neurogastroenterology & Motility, 25: 331–e252. doi: 10.1111/nmo.12078
- Issue published online: 22 MAR 2013
- Article first published online: 11 MAR 2013
- Received: 13 April 2012 Accepted for publication: 2 December 2012
- 9Randomised clinical trial: Bifidobacterium bifidum MIMBb75 significantly alleviates irritable bowel syndrome and improves quality of life--a double-blind, placebo-controlled study. Aliment Pharmacol Ther2011; 33: 1123–32., , et al.
- 10Clinical trial: the effects of a fermented milk containing three probiotic bacteria in patients with irritable bowel syndrome – a randomized, double-blind, controlled study. Aliment Pharmacol Ther2010; 31: 218–27., , et al.
- 19Clinical trial: the effects of a fermented milk product containing Bifidobacterium lactis DN-173-010 on abdominal distension and gastrointestinal transit in irritable bowel syndrome with constipation. Aliment Pharmacol Ther2009; 29: 104–14., , et al.
- 20Effect of a fermented milk containing Bifidobacterium animalis DN-173 010 on the health-related quality of life and symptoms in irritable bowel syndrome in adults in primary care: a multicentre, randomized, double-blind, controlled trial. Aliment Pharmacol Ther2007; 26: 475–86., , et al.
- 22Fermented milk containing Bifidobacterium animalis DN-173 010 improved self-reported digestive comfort amongst a general population of adults. A randomized, open-label, controlled, pilot study. J Dig Dis2009; 10: 61–70., , et al.
- 25Higgins JPT, Green S (eds) Cochrane Handbook for Systematic Reviews of Interventions, Version 5.0.1 (updated September 2008). The Cochrane Collaboration 2008. Available at: http://www.cochrane-handbook.org
- 28Gastrointestinal well-being in subjects reporting mild gastrointestinal discomfort: characteristics and properties of a global assessment measure. AGA abstracts. Gastroenterology2012; 142: S817–8., , , , .
- 29Guidance for Industry Irritable Bowel Syndrome – Clinical Evaluation of Drugs for Treatment. Draft guidance. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. May 2012.
- 30Committee for Proprietary Medicinal Products (CPMP). Points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome. CPMP/EWP/785/97. London, final document, March 19 2003.
- 34Committee for Proprietary Medicinal Products (CPMP). Statistical Principles for Clinical Trials (ICH Topic E 9). CPMP/ICH/363/96. European Medicines Agency, London, 1998
- 35Regression models for ordinal data. J R Statist Soc B1980; 42: 109–42..
- 36Categorical Data Analysis. 2nd edn. Hoboken, New Jersey: John Wiley & Sons, Inc., 2002..
- 38Meta-analysis using individual patient data. In: Meta-Analysis of Controlled Clinical Trials. (Statistics in Practice). Chichester; New York: John Wiley & Sons, 2002..
- 45A marketed fermented dairy product containing Bifidobacterium lactis CNCM I-2494 suppresses gut hypersensitivity and colonic barrier disruption induced by acute stress in rats. Neurogastroenterol Motil2012; 24: 376–e172. (doi: 10.1111/j.1365-2982.2011.01865.x)., , et al.