Trial | NCT00224432  Report issue

Title

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.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    45
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
Study Started
Mar 31
2001
Study Completion
Sep 30
2002
Last Update
Sep 27
2006
Estimate

Drug probiotics: Lactobacillus GG, lactobacillus Rhamnosus

Criteria 

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
No Results Posted