Management of Eczema by Specific Probiotic Strains (BAMBOO)

Agentschap NL

Status and phase

Withdrawn

Phase 3

Conditions

Atopic Dermatitis

Eczema

Treatments

Dietary Supplement: placebo

Dietary Supplement: Ecologic ® Panda II

Study type

Interventional

Funder types

Other

Identifiers

NCT01230190

BAMBOO

Details and patient eligibility

About

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).

Full description

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.

Sex

All

Ages

1 day to 15 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

children 0-15 months with mild to moderate eczema (SCORAD score 15-50 or equally EASI score) for at least two weeks

Exclusion criteria

use of topical steroids class II or higher (which means treatment for severe eczema),
use of oral steroids or treatment with antibiotics prior to inclusion.
severe comorbidity
lack of knowledge of the Dutch language