A randomized, double-blind, placebo-controlled intervention study to assess the therapeutic effect of an extensively hydrolyzed infant formula with an added synbiotic mixture in infants with atopic dermatitis.
- Conditions
- atopic dermatitiseczema1003871610040785
- Registration Number
- NL-OMON39465
- Lead Sponsor
- Danone Research - Centre for Specialised Nutrition
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 144
- Infants/children with atopic dermatitis
- up to and includig 10 months of age
- Expected daily intake of at least 500ml of the study product
- Intolerance for any other component of the study product(s)
- History of anaphylactic reaction to cow*s milk protein, including severe cardiovascular symptoms (shock), severe laryngeal edema, and bronchus obstruction.
- Use of antihistamines prior to (48 hours) the study.
- Use of oral steroids prior to (4 weeks) the study.
- Use of antibiotics or antimycotic drugs prior to (4 weeks) the study.
- History or presence of cardiovascular, gastrointestinal, hepatic, renal or respiratory chronic disease other than allergy.
- Major congenital abnormalities.
- Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome parameter in this study is the change of SCORAD after 4<br /><br>months of intervention.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome parameters in this study are:<br /><br>- The severity of exacerbations of atopic dermatitis.<br /><br>- The amount of topical steroids used.<br /><br>- The severity of asthma-like symptoms and asthma medication use.</p><br>