Colonization and Persistence Capacity of a Multi-strain Probiotics in Pediatric Food Allergy to Milk or Egg.
Condition: Food Hypersensitivity; Probiotic
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional

Summary: 
      This study evaluates the addition of three probiotics (Bifidobacterium longum,
      Bifidobacterium breve and Bifidobacterium infantis) in the treatment of pediatric food
      allergic children to milk or egg. The allergic participants will receive the probiotics,
      while other two populations age and sex matched of not confirmed allergic and healthy
      children will not receive probiotics.
    

Detailed description: 
      This study evaluates the colonization capacity of three probiotics (Bifidobacterium longum,
      Bifidobacterium breve and Bifidobacterium infantis) in milk and/or egg allergic children.

      It is expected the recruitment of about 20 egg and/or milk allergic patients aged between 10
      and 14 months old confirmed with double-blind oral tolerance test against placebo (Group 1).

      Furthermore, about 10 patients sensible to milk or egg but not confirmed with double-blind
      oral tolerance test against placebo (Group 2) will be recruited and about 10 healthy
      individuals (Group 3).

      For all 40 patients:

        1. Baseline presence of Bifidobacterium longum BB536, Bifidobacterium breve M-16V and
           Bifidobacterium infantis M-63 will be evaluated;

           Only for Group 1 children it will be also evaluate:

        2. The presence of the same strains during 30 days of administration of multi-strain
           probiotics containing 3.5 x 109 UFC of Bifidobacterium longum BB536, Bifidobacterium
           breve M-16V and Bifidobacterium infantis M-63 and after 60 days from the suspension of
           the administration.

      Quantification of B. breve, B. longum subsp. longum and B. longum subsp. infantis in faecal
      samples was carried out by qRT-PCR using the Light Cycler 480 platform (Roche Diagnostics,
      Mannheim, Germany). The assays were performed with a 20 µl PCR amplification mixture
      containing: 10 µl LightCycler 480 Probe Master mix (Roche Diagnostics), 2 µl primers and
      probes (optimized concentrations, 0.5 µM and 0.1 µM, respectively), 3 µl molecular-grade H2O
      and 5 µl DNA template. Each sample was tested in duplicate to ensure data reproducibility.
      The RT-PCR temperature profile consisted of an initial denaturation at 95°C for 10 min, 45
      amplification cycles at 95°C for 10 sec, 60°C for 30 sec and 72°C for 1 sec followed by a
      final cooling step at 40°C for 30 sec. Absolute quantification was performed using the
      "second derivative maximum method"

      Statistical analyses: Wilcoxon signed-rank test was used to compare probiotic species
      concentrations during the time-course.
    

Intervention name(s): Multi-strain probiotic
Intervention type(s): Dietary Supplement
Intervention description(s): 30 days of administration of multi-strain probiotics containing 3.5 x 109 UFC of Bifidobacterium longum BB536, Bifidobacterium breve M-16V and Bifidobacterium infantis M-63
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Probiotic; Food allergy