Rhinoconjunctivitis
Conditions
Keywords
E.coli, Mutaflor, grass pollen, rhinoconjunctivitis, rhinoconjunctivitis caused by grass pollen
Brief summary
Due to the worldwide increasing prevalence of the allergic rhinoconjunctivitis, new therapeutical strategies are needed. The symptomatic treatment with topical and systemic antihistamines and corticosteroids are often insufficient. E.coli Nissle 1917 has immunomodulatory capacities and reveals less side effects. E.coli Nissle 1917 has no sedative properties and exhibits no hepatotoxic qualities. Thus, E.coli Nissle 1917 represents a new relevant therapeutical agent.
Interventions
DRUGMutaflor
1 capsule contains 2.5 - 25 billion viable bacteria of the strain E. coli Nissle 1917, 1 capsule daily over the first 4 days, 2 capsules daily until the end of treatment
DRUGPlacebo
1 placebo capsule matching the experimental treatment, according to the experimental arm
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* clinical relevant grass pollen allergy with required treatment since 2 years * positive skin prick test to grass * positive sIgE towards grass (CAP 2) * written informed consent
Exclusion criteria
* perennial rhinoconjunctivitis * sinusitis * chronic diarrhoea and other existing severe gastrointestinal diseases * current specific immunotherapy to grass pollen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| symptom-medication score | 45 days |
Countries
Germany
Outcome results
None listed