ThreeLac is perfectly safe and this strain is too - FDA tested every year at the border. Here's more...
Here's a brief report indicating that certain enterococci strains may be useful in probiotics:
http://www.springerlink.com/content/f2x6462x83v80039/
And from the following:
http://cat.inist.fr/?aModele=afficheN&cpsidt=15738389
"E. faecalis EE4 and E. faecium EF01 showed the best probiotic properties. It indicates that they could be used as new candidate probiotic strains after in vivo testing."
And here:
http://www.cirval.univ-corse.fr/publication/tintenna/t18/enteroart.htm
Enterococci in Food Fermentations. Functional and Safety Aspects
A presentation of the UE - FAIR project CT97-3078
"Enterococci are typical Lactic Acid bacteria (LAB)."
"LAB are Generally Recognised As Safe (‘GRAS’) and, therefore, their safe use as starter cultures, or even as "probiotics", is generally not questioned."
"Information available on current probiotics supports their safety in food use. Safety studies have indicated no significant risk factors or virulence factors associated with probiotic enterococci thus far. Neither did surveillance studies report any current enterococcal probiotics to be involved in endocarditis or other bacteremia infections (Saxelin et al., 1996)."
"Presently, only the use and application of animal probiotics are regulated. This is based on Council Directive 70/524/EEC of 23 November 1970 on feed additives which has been amended recently by directive 1999/20/EC. Approval has so far been granted for the 5 enterococcal strains and a complete dossier was prepared according to Commission Directive 94/40/EC amending Council Directive 87/153/EEC. Regulation and formal mandatory approval of new LAB starter cultures for human use does not exist in the way it is being applied to animal probiotics. This practice is based on the long tradition of safe use and association of LAB in food fermentations and their "GRAS" status."
"Evidence was also provided to demonstrate the lack of pathogenicity and the lack of any adverse effects in volunteers during a six-week trial."
"Based on a long history of the safe association of particular enterococci with some traditional food fermentations, the use of such strains appears to bear no particular risk for human health. In fact, no infections have yet been related to food fermented according to good manufacturing procedures."
And another:
http://www.ajcn.org/cgi/content/full/73/2/365S
"In Germany, species such as L. rhamnosus, E. faecium, and E. faecalis have been grouped into risk group 2, ie, potential pathogens. The investigators responsible for this classification, however, concede that strains of these species with a documented safe history may belong to a risk group 1 (ie, species constituting no risk). Such strains that have found application in food fermentations or certain probiotic products for a long time are considered as safe."
PD Dr. E. DomannGiessenSymbioPharm GmbHHerborn Comparative genome analysis and monitoring of the probiotic strain Enterococcus faecalis S1-02-SASummaryThe term probiotica comprises viable microorganisms which generally benefit the health of the consumer after oral consumption. Important examples of human probiotic species and strains are Bifidobacterium ssp., Lactobacillus ssp., and non-pathogenic Enterococcus faecalis and Escherichia coli strains. The proposed health benefits of the ingested probiotica include: promotion of lactose digestion in lactose-intolerant individuals, resistance to enteric bacteria, anticarcinogenic, reduction of toxic impacts of small-bowel bacterial overgrowth, modulation of the gut immune system by reducing the pathological intestinal permeability for foreign antigens and by alleviating allergic diseases and reactions. However, little is known about the genetically encoded probiotic factors which accomplish the suspected benefits for human health.Aims and working planIn this project we aim at the production of a gapped genome sequence of the E. faecalis strain S1-02-SA which is an essential component of the probiotic products Prosymbioflor and Symbioflor 1 commercially distributed by SymbioPharm GmbH (Herborn, Germany). This particular probiotic has been in use for about 50 years and the health benefits have been assessed by double-blind placebo-controlled studies (Habermann et al., 2001). The main aims of the project are: First, generation and subsequent sequencing of small- and medium- sized recombinant library of the strain to 3-fold coverage. The sequenced will be assembled into contigs and aligned to the whole genome of a sequenced pathogenic E. faecalis isolate strain V583 (Acc. No. NC_004668; Paulsen et al., 2003) using the proprietary software package GenomeViz (Ghai et al., 2004). Regions unique to strain S1-02-SA will be used to design a specific TaqMan PCR amplicon for subsequent studies. Second, serial qualitative and quantitative monitoring of strain S1-02-SA in stool specimens of individuals taking the probiotic will be performed (Hossain et al., 2002). Third, we will use denaturing high-performance liquid chromatography “DHPLC” (Domann et al., 2003) to assess the impact of strain S1-02-SA on the composition of the individual stool flora of probands. These studies will contribute to the development of a microarray-based diagnostic chip for stool specimens to detect pathogens causing gastroenteritis, probiotic bacteria, and resident bacteria that is being carried out in close collaboration with alliance IV (Technology); Prof. Rolf Schmidt and Dr. Till Bachmann, University of Stuttgart, of the competence network PathoGenoMik.Literature: 1. Domann E, Hong G, Imirzalioglu C, Turschner S, Kühle J, Watzel C, Hain T, Hossain H, Chakraborty T. 2003. Culture-independent identification of pathogenic bacteria and polymicrobial infections in the genitourinary tract of renal transplant recipients. J. Clin. Microbiol. 41: 5500-5510.2. Ghai R, Hain T, Chakraborty T. 2004. GenomeViz – Visualizing Microbial Genomes. BMC Bioinformatics: in press.3. Habermann W, Zimmermann K, Skarabis H, Kunze R, Rusch V. 2001. Einfluß eines bakteriellen Immunstimulans (humane Enterococcus faecalis-Bakterien) auf die Rezidivhäufigkeit bei Patienten mit chronischer Bronchitis. Arzneimittelforschung 51:931-937.4. Hossain H, Chakraborty T, Domann E. 2002. TaqMan-PCR zum Nachweis von Salmonella enterica aus humanen Stuhlproben. Hyg. Mikrobiol. 6:196-201.5. Paulsen IT, et al. 2003. Role of mobile DNA in the evolution of vancomycin-resistant Enterococcus faecalis. Science 299:2071-2074.