Immunomodulation of E.Coli Nissle 1917 in Patients With Grass Pollen Rhinoconjunctivitis

Charite University, Berlin, Germany34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Rhinoconjunctivitis

Interventions

MutaflorDRUG

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

PlaceboDRUG

1 placebo capsule matching the experimental treatment, according to the experimental arm

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Charité - Universitätsmedizin Berlin

Berlin, Germany

Outcomes

Primary Outcomes

symptom-medication score

Time frame: 45 days

Data from ClinicalTrials.gov

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