Probiotic Bacteria to Infants With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007331
• Other study ID #: KF-D200 Probørn
• Status: Completed
• Phase: N/A
• First received: November 3, 2009
• Last updated: February 16, 2010
• Start date: November 2006
• Est. completion date: July 2008

Study information

• Verified date: November 2009
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 24 Months

Eligibility

Inclusion Criteria:

• Atopic dermatitis

Exclusion Criteria:

• Chronic diseases other than atopic dermatitis

• Chronic medication

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Behavioral:
• Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07
10^10 colony forming units pr day of probiotics

Locations

Country	Name	City	State
Denmark	Institute of Human Nutrition	Rolighedsvej 30	Frederiksberg C

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scoring atopic dermatitis (SCORAD) index		5 months	No
Secondary	Immunoglobulin E (IgE) Total		6 months	No
Secondary	Immunoglobulin E (IgE) specific for Egg		6 months	No
Secondary	Immunoglobulin E (IgE) specific for Milk		6 months	No
Secondary	Interleukin-10 (Il-10)		6 months	No
Secondary	Interleukin-12 (Il-12)		6 months	No
Secondary	Interferon gamma (IFN-gamma)		6 months	No
Secondary	Calprotectin		one year	No
Secondary	Polymerase Chain Reaction (PCR)		8 months	No
Secondary	Eosinophil Cation Protein (ECP)		7 months	No