Atopic Dermatitis Clinical Trial
Official title:
Beyond Conventional Treatment of Atopic Eczema in Infants: Management By Specific prObiOtic Strains
To investigate the therapeutic effect of a selected probiotic mixture on the severity of AD in infants aged 0-15 months. The probiotic mixture has been studied in laboratory setting and has proven IL-10 stimulating effects. Therefore it is thought to decrease AD severity in young children (beyond the conventional treatment).
Atopic dermatitis (AD) is a highly prevalent chronic, itching, inflammatory skin disease
that often presents in infancy. The disease can be the first manifestation of the so-called
atopic march, the natural progression of allergic disorders, with subsequent development of
asthma and allergic rhinitis. Approximately 40% of the children with AD will develop asthma
later in childhood.
Currently, topical corticosteroids are the mainstay treatment of atopic dermatitis; however,
relapses are common and parents often fear possible side-effects, leading to non-compliance.
There is increasing evidence that the intestinal microbiota plays an important role in the
development of allergic diseases. Modulation of the intestinal microbiota with probiotics,
living micro-organisms with immunomodulatory effects, could possibly offer a new way of
treatment of allergic disease.
Clinical trials investigating the preventive as well as therapeutic effect of probiotics on
atopic dermatitis show inconsistent results. Systematic (Cochrane) reviews of all clinical
trials (about treatment of AD by use of probiotics) concluded that the probiotic strains
studied to date are not an effective treatment for AD; however, there is great heterogeneity
between studies since many different probiotic strains are used. Because of the known strain
specific capacity in immunomodulatory effects, some strains might have a greater effect than
others.
Better results can possibly be achieved by using a selected, (in laboratory setting) proven
modulatory multispecies probiotic mixture, containing 6 different strains.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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