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Completed

NCT Number: NCT00677209

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

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".

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Key information

Conditions

Allergens, House Dust Mites Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Goethe University, Department of Pulmonology

Frankfurt am Main, Hesse, 60590, Germany

About this study

see above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Injection of autovaccine (Autovaccine Symbiopharm)

Biological

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

Primary outcomes

  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 outcomes

  1. Lung function,exhalative NO

    Time frame: jul 2006 - oct 2007

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

Frankfurt Investigator-initiated Autovaccine-study

Acronym: FIAVS

Important dates

Study start
2006
Primary completion
2008
Study completion
2010
First posted
May 14, 2008
Registry last updated
Dec 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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