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

This study has been completed.
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00677209
First received: May 12, 2008
Last updated: December 28, 2010
Last verified: May 2008
History of Changes
  Purpose

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 Intervention Phase
Allergens, House Dust Mites
 Biological: Injection of autovaccine (Autovaccine Symbiopharm)
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Frankfurt Investigator-initiated Autovaccine-study

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma
U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Patients' clinical parameters and behaviour, laboratory values [ Time Frame: jul 2006 - august 2008 ] [ Designated as safety issue: Yes ]
  • laboratory testing reflecting function of bone marrow, liver, kidney [ Time Frame: jul 2006- august 2008 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Lung function,exhalative NO [ Time Frame: jul 2006 - oct 2007 ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: July 2006
Study Completion Date: December 2010
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

see above

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00677209

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof Stefan Zielen, Childrens Hospital Goethe University
ClinicalTrials.gov Identifier: NCT00677209     History of Changes
Other Study ID Numbers: AVH-2004/1, Eudra-CT Nr. 2005-005534-12
Study First Received: May 12, 2008
Last Updated: December 28, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:
house dust mite
asthma
autovaccine
allergy

ClinicalTrials.gov processed this record on May 23, 2013