Probiotic Bacteria to Infants With Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT01007331|
Recruitment Status : Completed
First Posted : November 4, 2009
Last Update Posted : February 17, 2010
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Behavioral: Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07||Not Applicable|
The aim of the study is to investigate whether two different probiotics influence the clinical and subjective symptoms in infants with Atopic Dermatitis (AD). The influence on the immunologic status and the intestinal microflora, inflammation and permeability will also be investigated.
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:
- SCORing Atopic Dermatitis (SCORAD) index to describe the extent and severity of the eczema, and to describe the subjective symptoms.
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)
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Probiotic Bacteria to Infants With Atopic Dermatitis; an Investigation of the Effect on Eczema, Immunologic Status and the Intestinal Microflora, Inflammation and Permeability|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
- Behavioral: Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07
10^10 colony forming units pr day of probiotics
- Scoring atopic dermatitis (SCORAD) index [ Time Frame: 5 months ]
- Immunoglobulin E (IgE) Total [ Time Frame: 6 months ]
- Immunoglobulin E (IgE) specific for Egg [ Time Frame: 6 months ]
- Immunoglobulin E (IgE) specific for Milk [ Time Frame: 6 months ]
- Interleukin-10 (Il-10) [ Time Frame: 6 months ]
- Interleukin-12 (Il-12) [ Time Frame: 6 months ]
- Interferon gamma (IFN-gamma) [ Time Frame: 6 months ]
- Calprotectin [ Time Frame: one year ]
- Polymerase Chain Reaction (PCR) [ Time Frame: 8 months ]
- Eosinophil Cation Protein (ECP) [ Time Frame: 7 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01007331
|Institute of Human Nutrition|
|Rolighedsvej 30, Frederiksberg C, Denmark, 1958|
|Principal Investigator:||Kim F Michaelsen, Professor||Department of Human Nutrition, University of Copenhagen|