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

Frankfurt Investigator-initiated Autovaccine-study

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00677209
Acronym
FIAVS
Enrollment
8
Registered
2008-05-14
Start date
2006-07-31
Completion date
2010-12-31
Last updated
2010-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergens, House Dust Mites

Keywords

house dust mite, asthma, autovaccine, allergy

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.

Detailed description

see above

Interventions

BIOLOGICALInjection 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

Sponsors

Johann Wolfgang Goethe University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Patients' clinical parameters and behaviour, laboratory valuesjul 2006 - august 2008
laboratory testing reflecting function of bone marrow, liver, kidneyjul 2006- august 2008

Secondary

MeasureTime frame
Lung function,exhalative NOjul 2006 - oct 2007

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026