2719.pdf

Oryginał 
Scientific Opinion on the substantiation of health claims related to a combination of Lactobacillus fermentum 57A, Lactobacillus plantarum 57B and Lactobacillus gasseri 57C and defence against vaginal pathogens (ID 934, further assessment) pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup] EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3 European Food Safety Authority (EFSA), Parma, Italy ABSTRACT Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a health claim pursuant to Article 13 of Regulation (EC) No 1924/2006 in the framework of further assessment related to a combination of Lactobacillus fermentum 57A, Lactobacillus plantarum 57B and Lactobacillus gasseri 57C and defence against vaginal pathogens. The food constituent that is the subject of the claim, a combination of Lactobacillus fermentum 57A, Lactobacillus plantarum 57B and Lactobacillus gasseri 57C, is sufficiently characterised. The claimed effect, defence against vaginal pathogens, is a beneficial physiological effect. The target population is the female population. No human intervention studies were provided from which conclusions could be drawn for the scientific substantiation of the claim. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus fermentum 57A, Lactobacillus plantarum 57B and Lactobacillus gasseri 57C and defence against vaginal pathogens. © European Food Safety Authority, 2012
Słowa kluczowe: 57A   57B   57C   Lactobacillus fermentum   Lactobacillus gasseri   Lactobacillus plantarum   health claims   vaginal pathogens  
ID:    934  
Produkty: Lactobacillus fermentum 57A, Lactobacillus plantarum 57B, Lactobacillus gasseri 57C  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is a combination of Lactobacillus fermentum 57A, Lactobacillus plantarum 57B and Lactobacillus gasseri 57C.
For Lactobacillus fermentum 57A (hereafter L. fermentum 57A) a culture collection number from the Polish Collection of Microorganisms (PCM) (no. B/00007) was provided. The PCM has the status of International Depositary Authority under the Budapest Treaty. Data on the identification and characterisation of L. fermentum 57A at species and strain level using both phenotypic (colony morphology, carbohydrates fermentation and antibiotic resistance profiles) and genotypic (16S rRNA gene sequence analysis and 16S/23S intergenic spacer region sequence analysis, species-specific PCR, RAPD and PFGE) methods were provided in the application and accompanying references (Heczko, 2006, unpublished, 2008, unpublished; Pałucha, 2010, unpublished; Strus, 2010, unpublished). The Panel considers that L. fermentum 57A is sufficiently characterised.
For Lactobacillus plantarum 57B (hereafter L. plantarum 57B) a culture collection number from the PCM (no. B/00008) was provided. Data on the identification and characterisation of L. plantarum 57B at species and strain level using both phenotypic (colony morphology, carbohydrates fermentation and antibiotic resistance profiles) and genotypic (16S rRNA gene sequence analysis and 16S/23S intergenic spacer region sequence analysis, species-specific PCR, RAPD, PFGE and MLST) methods were provided in the application and accompanying references (Heczko, 2006, unpublished, 2008, unpublished; Pałucha, 2010, unpublished; Strus, 2010, unpublished). The Panel considers that L. plantarum 57B is sufficiently characterised.
For Lactobacillus gasseri 57C (hereafter L. gasseri 57C) a culture collection number from the PCM (no. B/00009) was provided. Data on the identification and characterisation of L. gasseri 57C at species and strain level using both phenotypic (colony morphology, carbohydrates fermentation and antibiotic resistance profiles) and genotypic (16S rRNA gene sequence analysis and 16S/23S intergenic spacer region sequence analysis, species-specific PCR, RAPD and PFGE) methods were provided in the application and accompanying references (Heczko, 2006, unpublished, 2008, unpublished; Pałucha, 2010, unpublished; Strus, 2010, unpublished). The Panel considers that L. gasseri 57C is sufficiently characterised.
The formulation, which is the subject of the claim, is the three bacterial strains in a ratio of L. gasseri 57C 50 %, L. fermentum 57A 25 %, and L. plantarum 57B 25 %.
The Panel considers that the food constituent, a combination of Lactobacillus fermentum 57A, Lactobacillus plantarum 57B and Lactobacillus gasseri 57C, which is the subject of the health claim, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect, which is proposed for further assessment, is “a beneficial effect on vaginal bacterial flora increasing total number of Lactobacillus rods, colonisation with tested strains and decreasing pH value and Nugent score”. The proposed target population is “women with no symptoms of urogenital tract infections but with disturbed or abnormal vaginal flora”.
The Panel notes that the claimed effect refers to defence against vaginal pathogens by increasing the number of lactobacilli and/or decreasing potentially pathogenic bacteria, and that the target population is the female population.
Unlike any other anatomical site of the body, most vaginal vaults are dominated by one or more species of Lactobacillus. In over 70 % of women, vaginal microbiota are dominated by lactobacilli (>50 %) (Ling et al., 2010; Ravel et al., 2010; Yamamoto et al., 2009). This microbiota is different from the more complex gut microbiota, where lactobacilli represent less than 3 % of the bacterial population (Franks et al., 1998; Lay et al., 2005; Sghir et al., 2000). The diagnosis of bacterial vaginosis (BV) can be based on, for example, the Nugent score (microscopic examination of Gram stained smear or vaginal discharge for bacteria and „clue‟ cells). The Panel notes that appropriate outcome measures of the claimed effect include assessment of the changes in the Nugent scores. Nugent scores are estimated by measuring the relative amounts of lactobacilli and bacterial pathogens present in the vagina. A Nugent score of 0-3 is classified as normal (lactobacilli are present, but not Gardnerella/Bacteroides or curved Gram-negative bacilli), a score of 4-6 as intermediate (colonisation by Gardnerella/Bacteroides and curved Gram-variable rods (Mobiluncus)), and a score of 7-10 is indicative of BV (with domination of Gardnerella/Bacteroides or curved Gram-negative bacilli and absence of lactobacilli).
The Panel considers that defence against vaginal pathogens is a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Ochrona przed patogenami pochwowymi przez zwiększenie ilości bakterii kwasu mlekowego i/lub zmniejszenie ilości potencjalnie patogennych bakterii lub drożdży

The references provided for the scientific substantiation of the claim included textbooks, narrative reviews, industrial certifications and consensus documents that did not provide original data for the scientific substantiation of the claim. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Among six human studies provided, four did not use the combination of bacterial strains which is the subject of the claim (Caillouette et al., 1997; Priestley et al., 1997; Samet et al., 2003; Vasquez et al., 2002). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Two references described the same human study (Strus et al., 2008; Strus et al., 2011, unpublished). In an open-label, not randomised, uncontrolled study the combination of the three bacterial strains which is the subject of the claim,was administered orally (1×109 CFU/day of lactic acid bacteria in the ratio: L. gasseri 57C 50 %, L. fermentum 57A 25 %, L. plantarum 57B 25 %) for 60 days to a group of outpatient women with intermediate Nugent score and increased vaginal pH but without clinical symptoms of urogenital infection to evaluate the colonisation of the vaginal epithelium by at least one of the given strains. The secondary endpoints included measurement of numbers of total lactobacilli in the vagina and rectum, vaginal pH, and Nugent score values. The Panel notes that this study was a
preliminary, open-label, uncontrolled study and considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
The animal and in vitro studies provided evaluated bacterial adhesion properties, bacterial binding to cell surfaces, production of hydrogen peroxide by bacteria, bacterial resistance to gastric acid and bile salts, and bactericidal activity. The Panel notes that no human intervention studies were provided from which conclusions could be drawn for the scientific substantiation of the claim. The Panel notes that animal and in vitro studies cannot predict the occurrence of an effect of a combination of Lactobacillus fermentum 57A, Lactobacillus plantarum 57B and Lactobacillus gasseri 57C on defence against vaginal pathogens in vivo in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of a combination of Lactobacillus fermentum 57A, Lactobacillus plantarum 57B and Lactobacillus gasseri 57C and defence against vaginal pathogens.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, a combination of Lactobacillus fermentum 57A, Lactobacillus plantarum 57B and Lactobacillus gasseri 57C, which is the subject of the health claim, is sufficiently characterised.
The claimed effect proposed for further assessment is “a beneficial effect on vaginal bacterial flora increasing total number of Lactobacillus rods, colonisation with tested strains and decreasing pH value and Nugent score”. The target population is the female population. Defence against vaginal pathogens is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of a combination of Lactobacillus fermentum 57A, Lactobacillus plantarum 57B and Lactobacillus gasseri 57C and defence against vaginal pathogens.