Double-Blind, Parallel, Randomised Study to Investigate the Effect of Oral Probiotics in Infants With Atopic Dermatitis
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2001
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 23, 2005
CompletedSeptember 27, 2006
September 1, 2006
September 13, 2005
September 26, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Significant decrease of SCORAD score in treated infants compared to placebo
Secondary Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beatrix Children's Hospital, University Medical Center Groningen
Groningen, 9700 RB, Netherlands
Related Publications (1)
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. doi: 10.1111/j.1365-2222.2006.02513.x.
PMID: 16839405RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 23, 2005
Study Start
March 1, 2001
Study Completion
September 1, 2002
Last Updated
September 27, 2006
Record last verified: 2006-09