Probiotics to infants with atopic dermatitis;an investigation of the effect on eczema, immune system and intestinal microflora, inflammation and permeability. DK-titelProbiotiske bakterier til børn med atopisk dermatitis;undersøgelse af effekten på eksem, immunstatus, intestinal mikroflorasamt tarmens inflammation og permeabilitet
- Conditions
- Infants participating in the clinical trial are suffering from atopic dermatitis
- Registration Number
- EUCTR2005-003140-56-DK
- Lead Sponsor
- Department of Human Nutrition, The Royal Veterinary and Agricultural University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Infants at the age of 5 months to 2 years with atopic dermatis, but otherwise
healthy
2. Infants should fulfil the criteria of atopic dermatitis
a. iching eczema within the past 6 weeks or chronic recurrent iching eczema
b. characteristic symmetrical body location of the eczema depending on age
c. clinical symptoms of atopic dermatitis on one or more of the following places:
face/neck; trunk; flexor aspects of arms or legs; extensor aspects of arms or
legs
d. hereditary disposition
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Infants suffering from chronic diseases other than atopic dermatits
2. Infants recieving medication from other diseases than atopic dermatitis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To investigate the influence of probiotics on :<br><br> 1. the clinical symptoms of atopic dermatitis using the SCORAD system<br> 2. the immune response in infants with atopic dermatitis<br> 3. the intestinal inflammation and permeability<br> 4. the general intestinal microflora<br><br>;Secondary Objective: 1. To decribe the probiotic influence on growth and body coposition in infants with <br> atopic dermatitis<br><br> 2. To investigate whether the cytokine and microflora of human milk influence the<br> development of atopic dermatitis in the offspring<br><br>;Primary end point(s): 1. Clinical improvement of the eczema<br><br> 2. Reduced intestinal inflammtion/pemeability
- Secondary Outcome Measures
Name Time Method