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CompletedNCT01007331Updated Feb 17, 2010

Probiotic Bacteria to Infants With Atopic Dermatitis

An interventional study of Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07 in Atopic Dermatitis, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to participants aged 6 Months to 24 Months. Per ClinicalTrials.gov, last updated 2010-02-17.

Sponsored by University of Copenhagen · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
6 Months to 24 Months
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Atopic Dermatitis

Keywords

  • Infants
  • Atopic Dermatitis
  • SCORAD
  • IgE
  • Eosinophil Cation Protein
  • Calprotectin
  • Intestinal microflora
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 62 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

University of Copenhagen is the lead sponsor of 449 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 24 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Atopic dermatitis

Exclusion criteria

Exclusion Criteria:

  • Chronic diseases other than atopic dermatitis
  • Chronic medication
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
62 participants (actual)

Interventions

  • BehavioralLactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07

    10\^10 colony forming units pr day of probiotics

06

What researchers measure

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

07

Study locations

1 site
  • Institute of Human Nutrition
    Rolighedsvej 30, Frederiksberg C 1958, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01007331
Lead sponsor
University of Copenhagen
First posted
Nov 4, 2009
Start date
Nov 2006
Primary completion
Jul 2008
Completion
Jul 2008
Last update
Feb 17, 2010

Study contacts

Kim F Michaelsen, Professor
principal investigator · Department of Human Nutrition, University of Copenhagen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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