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Double-Blind, Parallel, Randomised Study to Investigate the Effect of Oral Probiotics in Infants With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00224432
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : September 27, 2006
Sponsor:
Collaborator:
Numico Research Wageningen, the Netherlands
Information provided by:
Groningen Research Institute for Asthma and COPD

Brief Summary:
To study the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological parameters in infants with AD with and without CMA and to compare effectiveness of different strains of probiotics.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Atopic Eczema Infantile Eczema Drug: probiotics: Lactobacillus GG, lactobacillus Rhamnosus Not Applicable

Detailed Description:
  • To determine the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological parameters in infants with AD with and without CMA
  • To determine the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological reactivity to cow' milk challenge in infants with AD with CMA
  • To compare the effectiveness of different strains of probiotic bacteria in improving clinical and immunological outcome in these infants

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Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Double-Blind, Parallel, Randomised Study to Investigate the Clinical and Immunological Effects of Oral Administration of Probiotic Bacteria in Infants With Atopic Dermatitis With and Without Cow's Milk Allergy.
Study Start Date : March 2001
Study Completion Date : September 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema




Primary Outcome Measures :
  1. Significant decrease of SCORAD score in treated infants compared to placebo

Secondary Outcome Measures :
  1. IL-4, IL-5 and IFN-gamma production of stimulated peripheral blood mononuclear cells
  2. change in fecal TNF-α and α-1-antitrypsin, urinary EDN
  3. effect on faecal bacteria after probiotics


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Term infants fulfilling the Hanifin (1989) criteria for atopic dermatitis

    • Suggestive of CMA (one additional symptom)
    • Scorad index (total) >20 at study entry
    • Below 5 months of age
    • Formula, not breast fed
    • Written informed consent from the parents

Exclusion Criteria:

  • • Previous or current use of anti-histamines, oral corticosteroids, probiotics

    • Use of systemic antibiotic or anti-mycotic drugs in the previous 4 weeks
    • Congenital intestinal abnormality (eg. Hirschsprung's disease, intestinal atresia)
    • Other GI disease with intestinal inflammation and/or increased intestinal permeability
    • Skin disorder, not atopic dermatitis
    • Participation in another clinical study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224432


Locations
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Netherlands
Beatrix Children's Hospital, University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
Groningen Research Institute for Asthma and COPD
Numico Research Wageningen, the Netherlands
Investigators
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Principal Investigator: Eric J Duiverman, MD, PhD Dept of Pediatric Pulmonology, University Medical Center Groningen, The Netherlands
Principal Investigator: Marianne L Brouwer, MD Dept of Pediatric Pulmonology, University Medical Center Groningen, The Netherlands
Publications of Results:
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ClinicalTrials.gov Identifier: NCT00224432    
Other Study ID Numbers: METc/99/07/116
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: September 27, 2006
Last Verified: September 2006
Keywords provided by Groningen Research Institute for Asthma and COPD:
Atopic Dermatitis
SCORAD
probiotics
cytokines
Infant
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases