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

Charité University Medicine Berlin

Status and phase: Completed; Phase 2

Conditions: Rhinoconjunctivitis

Treatments: Drug: Placebo; Drug: Mutaflor

Study type: Interventional

Funder types: Other

Identifiers

NCT01013259

Ecorhino

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Mutaflor

Experimental group

Treatment:

Drug: Mutaflor