Clinical trial NCT01007331: Probiotic Bacteria to Infants With Atopic Dermatitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Infants
Atopic Dermatitis
SCORAD
IgE
Eosinophil Cation Protein
Calprotectin
Intestinal microflora
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2009-11-04
Enrollment: 62
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Atopic dermatitis

Exclusion Criteria:

* Chronic diseases other than atopic dermatitis
* Chronic medication

Primary outcomes:
measure: Scoring atopic dermatitis (SCORAD) index
timeFrame: 5 months
Secondary outcomes:
measure: Immunoglobulin E (IgE) Total
timeFrame: 6 months
measure: Immunoglobulin E (IgE) specific for Egg
timeFrame: 6 months
measure: Immunoglobulin E (IgE) specific for Milk
timeFrame: 6 months
measure: Interleukin-10 (Il-10)
timeFrame: 6 months
measure: Interleukin-12 (Il-12)
timeFrame: 6 months
measure: Interferon gamma (IFN-gamma)
timeFrame: 6 months
measure: Calprotectin
timeFrame: one year
measure: Polymerase Chain Reaction (PCR)
timeFrame: 8 months
measure: Eosinophil Cation Protein (ECP)
timeFrame: 7 months
Other outcomes:
Locations:
city: Rolighedsvej 30
country: Denmark
facility: Institute of Human Nutrition
state: Frederiksberg C
Study officials:
affiliation: Department of Human Nutrition, University of Copenhagen
name: Kim F Michaelsen, Professor
role: PRINCIPAL_INVESTIGATOR
References: