Clinical trial NCT01230190: Management of Eczema by Specific Probiotic Strains
Official title: Beyond Conventional Treatment of Atopic Eczema in Infants: Management By Specific prObiOtic Strains
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Eczema
Atopic Dermatitis
Keywords: infants
adaptive immunology
atopic dermatitis
probiotics
Lead sponsor: Agentschap NL
Sponsor class: OTHER_GOV
First posted: 2010-10-29
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: decrease in severity of atopic dermatitis
timeFrame: 6 months
Secondary outcomes:
measure: Effects on infant gut microbiota
timeFrame: 6 months
measure: Effects on the immature immune system
timeFrame: 6 months
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
state: Utrecht
Study officials:
affiliation: St. Antonius Hospital
name: Arine M Vlieger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: