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

December 28, 2010 updated by: Johann Wolfgang Goethe University Hospital

Frankfurt Investigator-initiated Autovaccine-study

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".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

see above

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

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

  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Goethe University, Department of Pulmonology

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

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Autovaccine Symbiopharm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patients' clinical parameters and behaviour, laboratory values
Time Frame: jul 2006 - august 2008
jul 2006 - august 2008
laboratory testing reflecting function of bone marrow, liver, kidney
Time Frame: jul 2006- august 2008
jul 2006- august 2008

Secondary Outcome Measures

Outcome Measure
Time Frame
Lung function,exhalative NO
Time Frame: jul 2006 - oct 2007
jul 2006 - oct 2007

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

  • Principal Investigator: Stefan Zielen, M.D., Ph.D., Goethe University, Department of Pulmonology

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.

General Publications

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

July 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

May 12, 2008

First Submitted That Met QC Criteria

May 12, 2008

First Posted (Estimate)

May 14, 2008

Study Record Updates

Last Update Posted (Estimate)

December 29, 2010

Last Update Submitted That Met QC Criteria

December 28, 2010

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AVH-2004/1
  • Eudra-CT Nr. 2005-005534-12

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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