Explorative analysis of the immunmodulatory capacities of apathogenic Escherichia coli Nissle 1917 in patients with rhinoconjunctivitis due to grass pollen allergy.
- Conditions
- Due to the worldwide increasing prevalence of allergic rhinoconjunctivitis (AR), new therapeutical strategies are needed. The symptomatic treatment with topical and systemic antihistamines and corticosteroids are often insufficient. E. coli Nissle 1917 (EcN) has immunmodulatory capacities and reveals less side effects. EcN has no sedative properties and exhibits no hepatotoxic and nephrotoxic qualities. Thus, EcN represents a new relevant therapeutical agent.
- Registration Number
- EUCTR2008-006335-12-DE
- Lead Sponsor
- Prof. Dr. med. Margitta Worm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 34
Age between 18 and 65 years (women and men)
Clinical relevat grass pollen allergy with required treatment of the rhinoconjunctivitis symptoms since at least 2 years
Positive skin prick test (SPT) to grass pollen extract
Positive specific IgE towards grass pollen (at least CAP class 2)
Written inform consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Perennial rhinoconjunctivitis
Chronic diarrhoe and other existing severe gastrointestinale diseases
Asthma bronchiale (Gina II - IV)
Use of Mutaflor® 12 weeks before the start of the trial
Use of antibiotics towards gram negative bacteria 4 weeks before the start of the trial
Specific immunotherapy to grass pollen 6 months before the start of the trial
Current specific immunotherapy to any allergen
Female patients: pregnancy and lactation period
Severe cardiovascular diseases and metabolic disorders, autoimmune diseases or other systemic inflammatory disorders
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method