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Probiotic Bacteria to Infants With Atopic Dermatitis

University of Copenhagen logo

University of Copenhagen

Status

Completed

Conditions

Atopic Dermatitis

Treatments

Behavioral: Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07

Study type

Interventional

Funder types

Other

Identifiers

NCT01007331
KF-D200 Probørn

Details and patient eligibility

About

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.

Full 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.

Enrollment

62 patients

Sex

All

Ages

6 to 24 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Atopic dermatitis

Exclusion criteria

  • Chronic diseases other than atopic dermatitis
  • Chronic medication

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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