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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

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 23, 2005
Last Update Posted Date September 27, 2006
Study Start Date  ICMJE March 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Significant decrease of SCORAD score in treated infants compared to placebo
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • IL-4, IL-5 and IFN-gamma production of stimulated peripheral blood mononuclear cells
  • change in fecal TNF-α and α-1-antitrypsin, urinary EDN
  • effect on faecal bacteria after probiotics
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Double-Blind, Parallel, Randomised Study to Investigate the Effect of Oral Probiotics in Infants With Atopic Dermatitis
Official Title  ICMJE 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.
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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Atopic Dermatitis
  • Atopic Eczema
  • Infantile Eczema
Intervention  ICMJE Drug: probiotics: Lactobacillus GG, lactobacillus Rhamnosus
Study Arms  ICMJE Not Provided
Publications * Brouwer ML, Wolt-Plompen SA, Dubois AE, van der Heide S, Jansen DF, Hoijer MA, Kauffman HF, Duiverman EJ. No effects of probiotics on atopic dermatitis in infancy: a randomized placebo-controlled trial. Clin Exp Allergy. 2006 Jul;36(7):899-906.

*   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
 (submitted: September 13, 2005)
45
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE September 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 5 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00224432
Other Study ID Numbers  ICMJE METc/99/07/116
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Groningen Research Institute for Asthma and COPD
Collaborators  ICMJE Numico Research Wageningen, the Netherlands
Investigators  ICMJE
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
PRS Account Groningen Research Institute for Asthma and COPD
Verification Date September 2006

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