NCT00677209CompletedPhase 1
Frankfurt Investigator-initiated Autovaccine-study
Johann Wolfgang Goethe University Hospital2 sites in 1 country8 target enrollmentStarted: July 1, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 8
- Locations
- 2
- Primary Endpoint
- Patients' clinical parameters and behaviour, laboratory values
Study Overview
Brief Summary
House dust mite allergy is a common problem, resulting in asthma, chronic swelling of the eyes, and running nose. The investigators test a possibility to immunize subjects sensitized against house dust mite with extracts from their own gut bacteria "auto-vaccination".
Detailed Description
see above
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •informed consent
- •age 18-35 years
- •known allergy on house-dust mite
Exclusion Criteria
- •anamnestic incompatibility to parts of autovaccine
- •asthma > GINA I°
- •chronic disease conditions or infections
- •pregnancy
- •inhalative or systemic steroid use
- •any immunosuppressive therapy
- •intake of any other probiotic medication (e.g. E.coli nissle 1917)
- •participation in any other study at the same time
- •substance abuse
- •Incapability of understanding the study's purpose and performance
Outcomes
Primary Outcomes
Patients' clinical parameters and behaviour, laboratory values
Time Frame: jul 2006 - august 2008
laboratory testing reflecting function of bone marrow, liver, kidney
Time Frame: jul 2006- august 2008
Secondary Outcomes
- Lung function,exhalative NO(jul 2006 - oct 2007)
Investigators
Study Sites (2)
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