CompletedNot Applicable

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

Netherlands45 participantsStarted 2001-03

Plain-language 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.

Who can participate

Age range0 Years – 5 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Significant decrease of SCORAD score in treated infants compared to placebo

Trial details

NCT IDNCT00224432

SponsorGroningen Research Institute for Asthma and COPD

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Atopic Dermatitis trials