Probiotic Bacteria to Infants With Atopic Dermatitis

Not Applicable

Completed

• Conditions: Atopic Dermatitis

• Registration Number: NCT01007331
• Lead Sponsor: University of Copenhagen

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.

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2009-11
• Study First Submitted: 2009-11-03
• Study First Submitted QC: 2009-11-03
• Study First Posted: 2009-11-04
• Last Update Submitted: 2010-02-16
• Last Update Posted: 2010-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Atopic dermatitis

Exclusion Criteria

• Chronic diseases other than atopic dermatitis
• Chronic medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Scoring atopic dermatitis (SCORAD) index	5 months

Secondary Outcome Measures

Name	Time	Method
Immunoglobulin E (IgE) Total	6 months
Immunoglobulin E (IgE) specific for Egg	6 months
Immunoglobulin E (IgE) specific for Milk	6 months
Interleukin-10 (Il-10)	6 months
Interleukin-12 (Il-12)	6 months
Interferon gamma (IFN-gamma)	6 months
Calprotectin	one year
Polymerase Chain Reaction (PCR)	8 months
Eosinophil Cation Protein (ECP)	7 months

Trial Locations

Locations (1)

Institute of Human Nutrition; 🇩🇰 Rolighedsvej 30, Frederiksberg C, Denmark