2851.pdf

Oryginał 
Scientific Opinion on the substantiation of a health claim related to Bifidobacterium animalis subsp. lactis LMG P-21384 and changes in bowel function (ID 2940, 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 (NDA) 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 in relation to Bifidobacterium animalis subsp. lactis LMG P-21384 and changes in bowel function. The food constituent that is the subject of the health claim, B. animalis subsp. lactis LMG P-21384, is sufficiently characterised. The claimed effect, changes in bowel function such as reduced transit time, more frequent bowel movements, increased faecal bulk, or softer stools may be a beneficial physiological effect, provided that it does not result in diarrhoea. 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 B. animalis subsp. lactis LMG P-21384 and changes in bowel function. © European Food Safety Authority, 2012
Słowa kluczowe: Bifidobacterium animalis subsp  
ID:    2940  
Produkty: Bifidobacterium lactis BS 01 (LMG P-21384)  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is Bifidobacterium lactis LMG P-21384 (BS 01), hereafter B. animalis subsp. lactis LMG P-21384, since the species B. lactis has been reclassified as B. animalis subsp. lactis (Masco et al., 2004).
A culture collection number from the Belgian Co-ordinated Collections of Microorganisms (BCCM/LMG) was provided (LMG P-21384). The BCCM/LMG is an internationally recognised culture collection which has the status of an International Depositary Authority under the Budapest Treaty. In the LMG, cultures can be deposited in a restricted-access collection for safe deposit or for patent purposes. Data on the identification and characterisation of B. animalis subsp. lactis LMG P-21384 at species and strain level, by using both phenotypic (enzymatic activity pattern, carbohydrate fermentation profile, PAGE, antibiotic resistance profiles) and genotypic (Rep-PCR, species-specific PCR, MLST, genome sequencing [publicly available at genbank, Project ID 59607]) methods, were provided in the application for further assessment and in the accompanying references (Del Piano et al., 2010).
The Panel considers that the food constituent, B. animalis subsp. lactis LMG P-21384, 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 “able to help restore and maintain a physiological intestinal motility by reducing the transit time in healthy adult subjects with mild to moderately decreased peristalsis (number of weekly evacuations less than 7) and evacuation disorders as straining and anal itching, burning, or pain during or after defecation”. The proposed target population is adults or the elderly reporting mild to moderately decreased intestinal motility and evacuation disorders.
The Panel considers that changes in bowel function such as reduced transit time, more frequent bowel movements, increased faecal bulk, or softer stools may be a beneficial physiological effect, provided that it does not result in diarrhoea.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Zmiany w funkcjonowaniu jelit (Pomoc w przywróceniu i utrzymaniu fizjologicznej perystaltyki jelit poprzez skrócenie czasu pasażu jelitowego u osób zdrowych, z łagodnym do umiarkowanego ograniczeniem perystaltyki (mniej niż 7 wypróżnień w tygodniu) i w problemach z wypróżnieniami, takimi jak swędzenie lub pieczenie odbytu lub ból podczas lub po defekacji)

In a randomised double-blind, placebo-controlled study, Del Piano et al. (2005) evaluated the effects of seven bacterial strains in the treatment of chronic constipation. Eighty subjects (59 females; 65-80 years) with a mean number of weekly evacuations less than 7 and not under antibiotic treatment were allocated to eight groups (10 subjects per group) to consume either placebo (maltodextrin) or one of the following bacterial strains at concentrations of 10x109 CFU: B. animalis subsp. lactis LMG P-21384 (B. lactis BS01), L. plantarum LP01, B. longum BL03, L. rhamnosus LR05, B. adolescentis BA02, L. paracasei LPC07, or B. breve BR03 for 15 days with a 15-day follow-up period. Almost all subjects were under medical treatment with, for example, anti-hypertensive medication, vasodilators, hypercholesterolaemic drugs or proton pump inhibitors. Subjects recorded the number of weekly defecations; consistency of faeces, ease of expulsion, sense of complete emptying, anal itching, and burning or pain during or after defecation were scored by the subjects on a three-point scale. Wilcoxon signed-rank test was used to compare results within groups. The Panel notes the insufficient information given on the randomisation and blinding of the study, that no information was provided on the validation of the scale used to score subjective symptoms, and that no between-group comparisons were reported. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
In another randomised double-blind, placebo-controlled study (Del Piano et al., 2010), 300 volunteers (recruited between 2003 and 2008) with evacuation disorders and hard stools (149 females; 24-71 years) were assigned to receive daily either placebo (n=80; maltodextrin), B. animalis subsp. lactis LMG P-21384 (B. lactis BS01) (n=110; 5x109 CFU) or a combination of L. plantarum LP01 (LMG P-21021) and B. breve BR03 (DSM 16604) (n=110; 2.5x109 CFU of each strain) for 30 days with a 15-day follow-up period. Subjects were asked to record in the week before each visit the number of weekly defecations; consistency of faeces, ease of expulsion, sensation of complete emptying, anal itching, burning and pain, and abdominal bloating were scored by the subjects on a three-point scale. Around 10 % of subjects dropped out from the study. Data were analysed by the independent Student t test. The Panel notes the insufficient information given on the randomisation and blinding of the study, that no information was provided on the validation of the scale used to score subjective symptoms, and that repeated measures, missing data and baseline values were not taken into account in the analysis. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
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 concludes that a cause and effect relationship has not been established between the consumption of B. animalis subsp. lactis LMG P-21384 and changes in bowel function.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, B. animalis subsp. lactis LMG P-21384, which is the subject of the health claim, is sufficiently characterised.
The claimed effect proposed for further assessment relates to changes in bowel function. The proposed target population is adults or the elderly reporting mild to moderately decreased intestinal motility and evacuation disorders. Changes in bowel function such as reduced transit time, more frequent bowel movements, increased faecal bulk, or softer stools may be a beneficial physiological effect, provided that it does not result in diarrhoea.
A cause and effect relationship has not been established between the consumption of B. animalis subsp. lactis LMG P-21384 and changes in bowel function.