The Effect of Autologous Autovaccine in Patients With Allergy on House-dust-mite
NCT ID: NCT00677209
Last Updated: 2010-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
8 participants
INTERVENTIONAL
2006-07-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
house dust mite allergics will undergo autovaccine immunization
Injection of autovaccine (Autovaccine Symbiopharm)
increasing dosage schedule, six different concentrations, application over six weeks, 2 weeks break, another six weeks, 2 weeks break, than challenge with inhalative house dust mite extract
Interventions
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Injection of autovaccine (Autovaccine Symbiopharm)
increasing dosage schedule, six different concentrations, application over six weeks, 2 weeks break, another six weeks, 2 weeks break, than challenge with inhalative house dust mite extract
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age 18-35 years
* known allergy on house-dust mite
* GINA 0-1
Exclusion Criteria
* 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
* smoker
18 Years
35 Years
ALL
No
Sponsors
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Johann Wolfgang Goethe University Hospital
OTHER
Responsible Party
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Childrens Hospital Goethe University
Principal Investigators
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Stefan Zielen, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Goethe University, Department of pulmonology
Locations
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Goethe University, Department of Pulmonology
Frankfurt am Main, Hesse, Germany
Countries
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References
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Halasa J. [Justification of treatment with autovaccine]. Med Dosw Mikrobiol. 1994;46(1-2 Suppl):5-9. No abstract available. Polish.
Schulze J, Voss S, Zissler U, Rose MA, Zielen S, Schubert R. Airway responses and inflammation in subjects with asthma after four days of repeated high-single-dose allergen challenge. Respir Res. 2012 Sep 19;13(1):78. doi: 10.1186/1465-9921-13-78.
Rose MA, Weigand B, Schubert R, Schulze J, Zielen S. Safety, tolerability, and impact on allergic inflammation of autologous E.coli autovaccine in the treatment of house dust mite asthma--a prospective open clinical trial. BMC Complement Altern Med. 2011 Jun 3;11:45. doi: 10.1186/1472-6882-11-45.
Other Identifiers
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Eudra-CT Nr. 2005-005534-12
Identifier Type: -
Identifier Source: secondary_id
AVH-2004/1
Identifier Type: -
Identifier Source: org_study_id