ID 902 -
Lactobacillus plantarum 299v
PL: Lactobacillus plantarum 299v
EN: Lactobacillus plantarum 299v
Pdf: Lactobacillus plantarum 299v
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is Lactobacillus plantarum 299v. The identification and characterisation of the strain Lactobacillus plantarum 299v by both phenotypic and genotypic methods is included in some of the studies provided as reference material (Johansson et al., 1993; 1995; 1998).
In the references provided, the deposit of the strain at the DSMZ (Deutsche Sammlung von Mikroorganismen und Zellkulturen) with a deposit number DSM 9843 is cited (Johansson et al., 1998; Klarin et al., 2005).
The Panel considers that the strain, Lactobacillus plantarum 299v, which is the subject of the health claims, is sufficiently characterised.
2.1. Redukcja wzdęć i gazów (ID 902)
The claimed effect is “digestive system”. The Panel assumes that the target population is the general population.
In the context of the proposed wording, the Panel assumes that the claimed effect refers to reducing flatulence and bloating. Excessive flatulence and bloating may cause abdominal pain and discomfort.
The Panel considers that reduction of flatulence and bloating is a beneficial physiological effect.
3.1. Redukcja wzdęć i gazów (ID 902)
A number of references provided for the scientific substantiation of the claim were unrelated to the food constituent which is the subject of the health claim, or were human, animal and in vitro studies on Lactobacillus plantarum 299v and effects other than reduction of flatulence and bloating. These references included studies related to the treatment of recurrent Clostridium difficile-associated diarrhoea, to effects on secretory response of intestinal epithelial cells to enteropathogenic Escherichia coli infection, to effects on bacterial translocation, and to plasma total antioxidant capacity, selenium status and faecal microbiota. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
Among the references cited, only three papers (Johansson et al., 1998; Niedzielin et al., 2001; Nobaek et al., 2000) addressed outcomes related to the claimed effect.
In a controlled and randomised, double-blind study (Johansson et al., 1998) 26 healthy adult volunteers consumed, for 21 days, 400 mL of a rose-hip drink containing oats (0.7 g/100 mL) fermented with Lactobacillus plantarum DSM 9843 (5x107 CFU/mL), and 22 volunteers in a second group the same amount of a pure rose-hip drink without oat (control, without the strain and without oat). The authors stated that the test product and placebo were comparable in texture and taste. Only at the end of the intervention were volunteers asked to note their overall bowel function observed during the intervention period. The results were reported by using analogue scales. The questions in the scales were: stool frequency, volume and consistency, difficulty with defecation and degree of flatulence. The Panel notes that this study was not appropriately controlled for other substances besides Lactobacillus plantarum DSM 9843, that no information was given on the background diets of subjects enrolled in the study, that it was not established that test and control groups were comparable at baseline with regard to the outcomes measured, that no information was given about the validation of the scale used, and that subjects were asked only at the end of the study periods to fill in the questionnaire evaluating the endpoints before and after intervention, for which reason recall bias cannot be excluded. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.
In another study (Nobaek et al., 2000), 60 patients with irritable bowel syndrome (IBS) and a normal colonoscopy or barium enema were randomised into two groups, one receiving 400 mL per day of a rose-hip drink containing 5x107 CFU/mL of Lactobacillus plantarum (DSM 9843) and 0.9 g/100 mL oat flour, and the other receiving a plain rose-hip drink without oat (control, without the strain and without oat), for four weeks. The authors stated that the test product and placebo were comparable in colour, texture, and taste. The patients recorded daily their gastrointestinal function in a questionnaire which included bloating and flatulence (the latter was recorded once a week), starting two weeks before the study and continuing throughout the study period. The Panel notes that this study was not
9v related health claims
7 EFSA Journal 2010;9(4):2037
appropriately controlled for other substances besides Lactobacillus plantarum DSM 9843, that no information was given on the background diets of subjects enrolled in the study and that no information was given about the validation of the scale used. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.
In the study by (Niedzielin et al., 2001), 40 patients (mean age 45 years, range 27-63 years) with irritable bowel syndrome (IBS) were randomised to receive 200 mL twice a day of a fruit drink containing 5 % oatmeal soup fermented with Lactobacillus plantarum 299v (5x107 CFU/mL; 20 patients) or of a placebo (fruit drink containing 5 % oatmeal soup without the strain) with identical appearance, smell and taste (20 patients) over a period of four weeks. Clinical examination was performed at baseline and at the end of the study. Additionally, patients assessed their symptoms on a weekly basis, applying a specially designed scoring system. The system included the three major symptoms of IBS: abdominal pain, stool frequency and consistency, and flatulence. The primary outcome measure was pain relief. The overall score was considered as the secondary outcome measure. The Panel notes that no information was given regarding the validation of the specially designed scoring system used, that no indication was provided that the study had been stratified a priori for the type of IBS with respect to symptoms, and that the statistical evaluation did not use a test allowing analysis of multiple repeated measures. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.
In weighing the evidence, the Panel took into account that no conclusions can be drawn for the scientific substantiation of the claimed effect from the three studies provided that addressed outcomes related to the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus plantarum 299v and reduction of flatulence and bloating.
Warunki i możliwe ograniczenia stosowania oświadczenia
at least 20x109 cfu/ day
