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The Effect of Autologous Autovaccine in Patients With Allergy on House-dust-mite (FIAVS)

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: NCT00677209
Recruitment Status : Completed
First Posted : May 14, 2008
Last Update Posted : December 29, 2010
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospital

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".

Condition or disease Intervention/treatment Phase
Allergens, House Dust Mites Biological: Injection of autovaccine (Autovaccine Symbiopharm) Phase 1

Detailed Description:
see above

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Frankfurt Investigator-initiated Autovaccine-study
Study Start Date : July 2006
Primary Completion Date : August 2008
Study Completion Date : December 2010

Arm Intervention/treatment
Active Comparator: A
house dust mite allergics will undergo autovaccine immunization
Biological: 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 Name: Autovaccine Symbiopharm



Primary Outcome Measures :
  1. Patients' clinical parameters and behaviour, laboratory values [ Time Frame: jul 2006 - august 2008 ]
  2. laboratory testing reflecting function of bone marrow, liver, kidney [ Time Frame: jul 2006- august 2008 ]

Secondary Outcome Measures :
  1. Lung function,exhalative NO [ Time Frame: jul 2006 - oct 2007 ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • informed consent
  • age 18-35 years
  • known allergy on house-dust mite
  • GINA 0-1

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
  • smoker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00677209


Locations
Germany
Goethe University, Department of Pulmonology
Frankfurt, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Principal Investigator: Stefan Zielen, M.D., Ph.D. Goethe University, Department of pulmonology