Clinical and immunological effects of the long term dietary supplementation with a probiotic fermented milk in pre-school children allergic to inhalants

Background and Aims: Probiotics may have immunomodulatory functions, exerting beneficial effects in allergic disease. We investigated whether prolonged daily consumption of Lactobacillus casei DN- 114 001 fermented milk improve clinical and immunological condition of children aged 3-6 years allergic to inhalants. Methods: In a randomised-controlled multicentric trial patients were randomly assigned to receive for one year 100 ml per day of L. casei DN-114 001 fermented milk (109 cells/ml), or no probiotics (controls). Clinical evaluations occurred every 3 months. Faecal flora composition was assessed every 6 months (30 treated, 15 controls). Outcome measures were allergy-related signs incidence, infections incidence/severity, IgE-G-A serological levels (baseline vs 12 months). Results: Participants (187; 92 treated) were similar regarding gestational age, breastfeeding, family smokers, pets, siblings, day-care admission. Supplemented children exibited less rhinitis episodes than controls up to T6 [mean-SD: 0,6 (1) vs 0,9 (1,1) at T3, p= 0,031; 1 (2,6) vs 1,6 (2) at T6, p=0,027]. Asthma and infections incidence/severity did not differ between groups. IgE mean % variation increased in controls at T12 vs baseline (+ 25%; p< 0,01) but not in the treated group (+8%; p=0,59). IgG and IgA mean % variation significantly increased in treated group (+6,3% and +11,5% respectively; p< 0,01) but not in controls (2,4% and 3,7% respectively; p=0,34 and 0,19). Faecal analysis showed Lactobacillus casei DN-114 001 in the gut flora of 78% of supplemented children through the study period. Conclusions: Long-term daily consumption of Lactobacillus Casei DN-114 001 fermented milk may positively influence on the clinical and immunological status of allergic children