Double-Blind, Parallel, Randomised Study to Investigate the Effect of Oral Probiotics in Infants With Atopic Dermatitis

Double-Blind, Parallel, Randomised Study to Investigate the Clinical and Immunological Effects of Oral Administration of Probiotic Bacteria in Infants With Atopic Dermatitis With and Without Cow's Milk Allergy.

To study the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological parameters in infants with AD with and without CMA and to compare effectiveness of different strains of probiotics.

• To determine the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological parameters in infants with AD with and without CMA
• To determine the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological reactivity to cow' milk challenge in infants with AD with CMA
• To compare the effectiveness of different strains of probiotic bacteria in improving clinical and immunological outcome in these infants

Inclusion Criteria:

• Term infants fulfilling the Hanifin (1989) criteria for atopic dermatitis

  • Suggestive of CMA (one additional symptom)
  • Scorad index (total) >20 at study entry
  • Below 5 months of age
  • Formula, not breast fed
  • Written informed consent from the parents

Exclusion Criteria:

• • Previous or current use of anti-histamines, oral corticosteroids, probiotics

  • Use of systemic antibiotic or anti-mycotic drugs in the previous 4 weeks
  • Congenital intestinal abnormality (eg. Hirschsprung's disease, intestinal atresia)
  • Other GI disease with intestinal inflammation and/or increased intestinal permeability
  • Skin disorder, not atopic dermatitis
  • Participation in another clinical study