Probiotic Bacteria to Infants With Atopic Dermatitis

This study has been completed.

Sponsor:

Information provided by:

University of Copenhagen

ClinicalTrials.gov Identifier:

NCT01007331

First received: November 3, 2009

Last updated: February 16, 2010

Last verified: November 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

November 3, 2009

Last Updated Date

February 16, 2010

Start Date ^ICMJE

November 2006

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Scoring atopic dermatitis (SCORAD) index [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

SCORAD
IgE
IL-10
IL-12
IFN-gamma
Calprotectin
Alpha-1-antitrypsin
TRFLP
Q-PCR

Change History

Complete list of historical versions of study NCT01007331 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Immunoglobulin E (IgE) Total [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Immunoglobulin E (IgE) specific for Egg [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Immunoglobulin E (IgE) specific for Milk [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Interleukin-10 (Il-10) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Interleukin-12 (Il-12) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Interferon gamma (IFN-gamma) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Calprotectin [ Time Frame: one year ] [ Designated as safety issue: No ]
Polymerase Chain Reaction (PCR) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Eosinophil Cation Protein (ECP) [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

IL-8 from milk samples
ECP from milk samples

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Probiotic Bacteria to Infants With Atopic Dermatitis

Official Title ^ICMJE

Probiotic Bacteria to Infants With Atopic Dermatitis; an Investigation of the Effect on Eczema, Immunologic Status and the Intestinal Microflora, Inflammation and Permeability

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:

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Atopic Dermatitis

Intervention ^ICMJE

Behavioral: Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07

10^10 colony forming units pr day of probiotics

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Atopic dermatitis

Exclusion Criteria:

Chronic diseases other than atopic dermatitis
Chronic medication

Gender

Both

Ages

6 Months to 24 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01007331

Other Study ID Numbers ^ICMJE

KF-D200 Probørn

Has Data Monitoring Committee

Responsible Party

Kim Fleischer Michaelsen, Department of Human Nutrition, University of Copenhagen

Study Sponsor ^ICMJE

University of Copenhagen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kim F Michaelsen, Professor

Department of Human Nutrition, University of Copenhagen

Information Provided By

University of Copenhagen

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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