Status:
COMPLETED
Double-Blind, Parallel, Randomised Study to Investigate the Effect of Oral Probiotics in Infants With Atopic Dermatitis
Lead Sponsor:
Groningen Research Institute for Asthma and COPD
Collaborating Sponsors:
Numico Research Wageningen, the Netherlands
Conditions:
Atopic Dermatitis
Atopic Eczema
Eligibility:
All Genders
Up to 5 years
Phase:
NA
Brief 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 ...
Detailed Description
* 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 ...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
End Date :
September 1 2002
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00224432
Start Date
March 1 2001
End Date
September 1 2002
Last Update
September 27 2006
Active Locations (1)
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1
Beatrix Children's Hospital, University Medical Center Groningen
Groningen, Netherlands, 9700 RB