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Completed

NCT Number: NCT01007331

Probiotic Bacteria to Infants With Atopic Dermatitis

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Human Nutrition

Rolighedsvej 30, Frederiksberg C, 1958, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Atopic dermatitis

Exclusion criteria

  • Chronic diseases other than atopic dermatitis
  • Chronic medication

Treatment and study plan

Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07

Behavioral

10^10 colony forming units pr day of probiotics

Primary outcomes

  1. Scoring atopic dermatitis (SCORAD) index

    Time frame: 5 months

Secondary outcomes

  1. Immunoglobulin E (IgE) Total

    Time frame: 6 months

  2. Immunoglobulin E (IgE) specific for Egg

    Time frame: 6 months

  3. Immunoglobulin E (IgE) specific for Milk

    Time frame: 6 months

  4. Interleukin-10 (Il-10)

    Time frame: 6 months

  5. Interleukin-12 (Il-12)

    Time frame: 6 months

  6. Interferon gamma (IFN-gamma)

    Time frame: 6 months

  7. Calprotectin

    Time frame: one year

  8. Polymerase Chain Reaction (PCR)

    Time frame: 8 months

  9. Eosinophil Cation Protein (ECP)

    Time frame: 7 months

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 4, 2009
Registry last updated
Feb 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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