- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00224432
Double-Blind, Parallel, Randomised Study to Investigate the Effect of Oral Probiotics in Infants With Atopic Dermatitis
September 26, 2006 updated by: Groningen Research Institute for Asthma and COPD
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Groningen, Netherlands, 9700 RB
- Beatrix Children's Hospital, University Medical Center Groningen
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second to 5 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Significant decrease of SCORAD score in treated infants compared to placebo
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Secondary Outcome Measures
Outcome Measure |
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IL-4, IL-5 and IFN-gamma production of stimulated peripheral blood mononuclear cells
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change in fecal TNF-α and α-1-antitrypsin, urinary EDN
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effect on faecal bacteria after probiotics
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- 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 and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2001
Study Completion
September 1, 2002
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 23, 2005
Study Record Updates
Last Update Posted (Estimate)
September 27, 2006
Last Update Submitted That Met QC Criteria
September 26, 2006
Last Verified
September 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- METc/99/07/116
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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