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

Phase 2

Completed

• Conditions: Rhinoconjunctivitis
• Interventions: Drug: Mutaflor; Drug: Placebo

• Registration Number: NCT01013259
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2009-09
• Study Completion: 2009-10
• Status Verified: 2009-11
• Study First Submitted: 2009-11-10
• Study First Submitted QC: 2009-11-12
• Last Update Submitted: 2009-11-12
• Study First Posted: 2009-11-13
• Last Update Posted: 2009-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mutaflor	Mutaflor	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
symptom-medication score	45 days

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany