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

• Status: Completed
• Trial end date: 2002-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groningen Research Institute for Asthma and COPD
• Collaborator: Numico Research Wageningen, the Netherlands

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