2.1. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 2959)

The claimed effect is “microflora/intestinal transit/intestinal health”. The Panel assumes that the target population is the general population.
From the clarifications provided by Member States, the Panel assumes that the claimed effect refers to changes in the number of gastro-intestinal microorganisms.
The numbers/proportions of bacterial groups that would constitute a “balanced intestinal microflora” have not been established. Increasing numbers of any group of microorganisms is not in itself considered to be a beneficial physiological effect.
The Panel considers that decreasing potentially pathogenic gastro-intestinal microorganisms might be a beneficial physiological effect.

2.2. Utrzymanie prawidłowego czasu pasażu jelitowego (ID 2959)

The claimed effect is “microflora/intestinal transit/intestinal health”. The Panel assumes that the target population is the general population.
The Panel considers that maintenance of a normal intestinal transit time might be a beneficial physiological effect.

2.3. Zmniejszenie dolegliwości ze strony przewodu pokarmowego (ID 2959)

The claimed effect is “microflora/intestinal transit/intestinal health”. The Panel assumes that the target population is the general population.
From the clarifications provided by Member States, the Panel assumes that the claimed effect refers to the reduction of gastro-intestinal discomfort.
The Panel considers that reduction of gastro-intestinal discomfort is a beneficial physiological effect.

3.1. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 2959)

No human studies were provided that addressed endpoints related to decreasing potentially pathogenic gastro-intestinal microorganisms.
One human intervention study investigated the effect of a formulation containing L. paracasei B21060 in patients with irritable bowel syndrome (e.g. improvement of abdominal pain), but did not address outcomes related to pathogens (Andriulli et al., 2008). The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect.
An in vitro study investigated the ability of the strain L. paracasei B21060 to inhibit the growth of pathogens in co-culture (Escherichia coli, Salmonella enteritidis or Vibrio cholerae) (Drago et al., 1997). The Panel considers that while effects shown in animal and in vitro studies may be used as supportive evidence, human studies are required for the substantiation of a claim, and that evidence provided in in vitro studies alone is not sufficient to predict an effect of L. paracasei B21060 consumption on decreasing potentially pathogenic gastro-intestinal microorganisms in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of L. paracasei B21060 and decreasing potentially pathogenic gastro-intestinal microorganisms.

3.2. Utrzymanie prawidłowego czasu pasażu jelitowego (ID 2959)

No human studies were provided which addressed endpoints related to intestinal transit time.
The Panel concludes that a cause and effect relationship has not been established between the consumption of L. paracasei B21060 and maintenance of a normal intestinal transit time.

3.3. Zmniejszenie dolegliwości ze strony przewodu pokarmowego (ID 2959)

The effect of L. paracasei B21060 was tested in one randomised, double-blind, controlled parallel- group trial on patients aged 18-72 years who fulfilled the Rome II criteria of Irritable Bowel Syndrome (IBS) (Andriulli et al., 2008). Subjects were excluded if antibiotics had been used prior to the study (<12 weeks). After a 2-week run-in period, 267 subjects were randomised to consume twice daily Flortec powder (containing 5x109 CFU L. paracasei B21060, 700 mg xylo-oligosaccharides, 500 mg glutamine and 1,243 mg arabinogalactone) or the matching control formulation (without the strain) for 12 weeks. Baseline demographics of the enrolled subjects were reported to be similar in the two groups. The primary comparison for efficacy was the responder rate for pain and global satisfactory relief reported by the patients; responder being defined as patients who have described the pain as absent or mild, and the overall self-reported satisfactory relief from symptoms as completely or considerably relieved. The analysis was carried out on the intention-to-treat population. Sample size was calculated assuming a response rate of 30 % in the control group and 50 % in the treatment group, and that 130 patients per treatment arm would be sufficient to achieve 90 % power in detecting a treatment difference at a significance level of 0.05. At treatment week four, the proportion of patients reporting absent or mild pain amounted to 54 % in the treatment group and to 57.4 % in controls. At treatment week eight, rates were 60.9 % and 53.9 % in the two experimental groups, respectively. At the end of treatment, percentages of patients with a benefit from treatment were 53.9 % vs. 53.4 % in the control group. No significant difference emerged between the two treatment groups at any time in the intention-to-treat analysis. A secondary comparison for efficacy was also carried out in the subgroups of 47 IBS patients with diarrhoea-predominance. It is unclear whether the study has been stratified a priori for the type of IBS (with diarrhoea, with constipation or with alternating constipation and diarrhoea). Hence, no conclusion can be drawn from the result of the subgroup analysis. The Panel also notes that the endpoints measured were based on daily records by patients in a diary of symptoms, and no reference to the validation of the measurement scales for the symptom scores was indicated.
In weighing the evidence, the Panel took into account that the one human intervention study submitted failed to show a significant difference in the intention-to-treat analysis.
The Panel concludes that a cause and effect relationship has not been established between the consumption of L. paracasei B21060 and the reduction of gastro-intestinal discomfort.