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Biosafety evaluation of probiotic lactic acid bacteria
used for human consumption

Contract number : QLK1-2001-01273
Contract type : Shared Cost Project
Total cost : € 1.687.746
EC contribution : € 1.281.461
Starting date : 1/01/2002
Duration : 48 Months
Scientific Officer : Jürgen Lucas
Project website :
Prof. Dr Herman Goossens
Universiteit Antwerpen
Universitair Ziekenhuis Antwerpen
Department of Medical Microbiology
Wilrijkstraat 10
2650 Edegem
Tel.: +32-3-8213789
Fax: +32-3-8254281
E-mail: herman.goossens @

Probiotic bacteria, mainly lactic acid bacteria (LAB) (e.g. lactobacilli, lactococci, enterococci, and bifidobacteria) have been considered safe for human consumption. However, recent reports of clinical infection, the spread of antibiotic resistance genes, and development of new and/or modified probiotic LAB strains, have caused concern of safety. This project aims to assess the biosafety of LAB. Isolates from healthy humans and immunocompromised patients, commercially available and new probiotic LAB will be studied. After polyphasic taxonomic identification, their biosafety will be assessed by several methods (see objectives). The project will result in recommendations for biosafe and biosafety testing of LAB.


Overall objective: The safe use of probiotic Lactic Acid Bacteria (LAB) (e.g. lactobacilli, lactococci, enterococci, bifidobacteria) for human consumption, by proposing criteria, standards, guidelines, and regulations on the one hand, and procedures and standardised methodologies of pre-marketing biosafety testing and post-marketing surveillance on the other hand.

Specific objectives:

  • Taxonomic description of probiotic and other LAB;
  • Detection of resistance and horizontal transfer of antibiotic resistance genes among LAB;
  • Detection of known and new virulence properties of LAB;
  • Immunological adverse effects of LAB in the EAE model;
  • Survival, colonisation, and genetic stability of probiotic LAB in the human gut.
(expected) Results and achievements
  • Culture collection and database of probiotic and other LAB.
  • Standardised methodologies to detect antibiotic resistance in LAB.
  • Investigation of (potential) virulence properties in LAB, and their association with clinical disease and results obtained in rat endocarditis model.
  • Potential immunological adverse effects of LAB.
  • Genetic stability and colonisation of probiotic LAB in the human gastro-intestinal gut.
  • Recommendations for biosafety evaluation of probiotic LAB.


Universiteit Gent
BCCM/MLG Bacteria Collection
Laboratorium voor Microbiologie
Vakgroep Biochemie, Fysiologie en Microbiologie
K.L. Ledeganckstraat 35
9000 Gent
Robert Koch Institut
Laboratory of Nosocomial Infections
Burgstraße 37
38855 Wernigerode
Université de Lille 2
Laboratoire de Bactériologie
Faculté des Sciences Pharmaceutiques
Rue du Professeur Laguesse
BP 83
59006 Lille
Centre Hospitalier Universitaire Vaudois
Rue du Bugnon 46
1011 Lausanne
Numico Research B.V.
Bosrandweg 20
PO Box 7005
6704 PH Wageningen
The Netherlands
Leiden University Medical Center
Dpt of Medical Microbiology
PO Box 9600
Albinusdreef 2
2300 RC Leiden
The Netherlands

Fifth Framework Programme

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