Study to assess the effect of an added Synbiotic mixture on Atopic dermatitis in INfanTs.
Completed
- Conditions
- Atopic Dermatitis
- Registration Number
- NL-OMON23678
- Lead Sponsor
- This clinical study will be performed within TOP Institute Pharma (project T1-501). Besides Danone Research, also the Academic Medical Center (AMC) Amsterdam, Wilhelmina Children's Hospital (WKZ) Utrecht, VU University Amsterdam, and the Utrecht Institute for Pharmaceutical Sciences (UIPS) will participate in the TOP Institute Pharma project. Danone Research shall take care of the Sponsor responsibilities as defined by ICH-GCP'.
- Brief Summary
Hulshof L, Overbeek SA, Wyllie AL, Chu MLJN, Bogaert D, de Jager W, Knippels LMJ, Sanders EAM, van Aalderen WMC, Garssen J, Van ’t Land B, Sprikkelman AB. Exploring Immune Development in Infants With Moderate to Severe Atopic Dermatitis. Front Immunol., 2018;9:630.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 144
Inclusion Criteria
1. Infants/children with atopic dermatitis;
2. Between 0-8 months of age;
Exclusion Criteria
1. Intolerance for any other component of the study product(s);
2. History of anaphylactic reaction to cow's milk protein, including severe cardiovascular symptoms (shock), severe laryngeal edema, and bronchus obstruction;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome parameter in this study is the change of SCORAD after 4 months of intervention.
- Secondary Outcome Measures
Name Time Method 1. The severity of exacerbations of atopic dermatitis, measured by SCORAD, Adverse Events and concomitant medication;<br /><br>2. The amount and class of topical steroids used;<br /><br>3. The severity of asthma-like symptoms and asthma medication use.