Beyond conventional treatment of Atopic eczema in infants: Management By specific prObiOtic strains. A double blind placebo-controlled trial.

Phase 3

Withdrawn

Conditions: 10014982
allergy
atopic dermatitis
eczema
10001708

Registration Number: NL-OMON34286

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

age 0-15 months
atopic dermatitis for at least 2 weeks, with SCORAD score 15-50

Exclusion Criteria

class II or higher class topical corticosteroid use, or use of systemic corticosteroids
antibiotic treatment just before enrollment or in the first week of the study
syndromal abnormalities, major medical problems
lack of knowledge of the Dutch language

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary goal: Is there a decrease in severity of atopic dermatitis (AD) in<br /><br>young children by daily supply of a multispecies probiotic mixture?<br /><br>The primary outcome will be measured by change in the severity of AD by using<br /><br>the SCORAD score.<br /><br><br /><br>Secondary outcomes: subjective (parental) change in eczema severity, change in<br /><br>amount of and type of topical steroid use, quality of life during and after<br /><br>intervention (measured by the validated ITQOL questionnaire), amount of<br /><br>respiratory tract infections, use of antibiotics, use of primary care medicine<br /><br>(general practitioner), change of microbiota composition, change in cytokine<br /><br>pattern.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Effects on infant gut microbiota<br /><br>Analyses will be done by molecular microbiological techniques on feces samples<br /><br>(that will be collected at baseline, and after 1,3 and 6 months after<br /><br>enrollment.<br /><br>-Effects on the immature immune system<br /><br>These effects will be measured by analyzing serum IgE and different (Th1/Th2)<br /><br>cytokines and chemokines</p><br>