Trials / Completed
CompletedNCT01007331
Probiotic Bacteria to Infants With Atopic Dermatitis
Probiotic Bacteria to Infants With Atopic Dermatitis; an Investigation of the Effect on Eczema, Immunologic Status and the Intestinal Microflora, Inflammation and Permeability
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- University of Copenhagen · Academic / Other
- Sex
- All
- Age
- 6 Months – 24 Months
- Healthy volunteers
- Not accepted
Summary
The objective of the study is to examine whether 8 weeks intervention with probiotics influence the eczema in infants suffering from Atopic Dermatitis. Furthermore the influence of the immunologic status and the intestinal microflora, inflammation and permeability will be investigated.
Detailed description
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: 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
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07 | 10\^10 colony forming units pr day of probiotics |
Timeline
- Start date
- 2006-11-01
- Primary completion
- 2008-07-01
- Completion
- 2008-07-01
- First posted
- 2009-11-04
- Last updated
- 2010-02-17
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT01007331. Inclusion in this directory is not an endorsement.