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.
Conditions
Interventions
Trade Name: Mutaflor
Pharmaceutical Form: Gastro-resistant capsule, hard
Other descriptive name: E. coli Nissle 1917 (concentration unit: cfu = colony forming units)
Concentration type: range
Concentr
Sponsors
Prof. Dr. med. Margitta Worm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The anti-allergic immunmodulatory effect of EcN on the immune system and the clinical symptoms of patients with seasonal AR to grass pollen will be assessed in an exploratory trial in comparison to placebo. The primary endpoint is the symptom-medication score (SMS) in the grass pollen season. ;Secondary Objective: ;Primary end point(s): The primary endpoint is to show the anti-allergic immunmodulatory effect of EcN determined by the symptom-medication score (SMS) in the grass pollen season in an exploratory trial in comparison to placebo. The SMS will be calculated by the daily sum of symptoms and the use of anti-allergic medication documented in patient diaries during grass pollen season. Documentation period of patient diaries covers 6 month per year. The exact period of analysis the SMS as area under the curve (AUC) will be defined on the basis of the real pollen counts occurred in the study year. The exact period of analysis the AUC of SMS will be a period of 45 days (14 days before and 31 days after the peak of grass pollen count. | — |
Countries
Germany
Outcome results
None listed