Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2006-11-30
2008-07-31
Brief Summary
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Detailed Description
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Sixty two infants (6 to 24 months of age) suffering from AD will be randomised in 3 groups receiving either Lactobacillus acidophilus NCFM (1x10\^10 Colony forming units), Bifidobacterium lactis Bi-07(1x10\^10 Colony forming units) or placebo every day for 8 weeks.
At the beginning and at the end of the study the following analyses will be made:
1. SCORing Atopic Dermatitis (SCORAD) index to describe the extent and severity of the eczema, and to describe the subjective symptoms.
2. Blood samples will be drawn to examine:
* Immunoglobulin E (IgE), total and specific for egg and milk.
* Eosinophil Cation Protein (ECP)
* Interleukin-10 (Il-10), Interleukin-12 (Il-12) and Interferon-gamma (IFN-gamma)
3. Fecal samples will be collected to examine:
* Calprotectin (intestinal inflammation)
* Bacterial Deoxyribonucleic acid (DNA) will be extracted in order to perform Polymerase chain reaction (PCR) analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Interventions
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Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07
10\^10 colony forming units pr day of probiotics
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Chronic medication
6 Months
24 Months
ALL
No
Sponsors
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University of Copenhagen
OTHER
Responsible Party
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Department of Human Nutrition, University of Copenhagen
Principal Investigators
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Kim F Michaelsen, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Human Nutrition, University of Copenhagen
Locations
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Institute of Human Nutrition
Rolighedsvej 30, Frederiksberg C, Denmark
Countries
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Other Identifiers
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KF-D200 Probørn
Identifier Type: -
Identifier Source: org_study_id
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