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

Rhinoconjunctivitis Clinical Trial

— Ecorhino  

Official title:

Explorative Analysis of the Immunomodulatory Capacities of Apathogenic Escherichia Coli Nissle 1917 in Patients With Rhinoconjunctivitis Due to Grass Pollen Allergy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01013259
• Other study ID #: Ecorhino
• Status: Completed
• Phase: Phase 2
• First received: November 10, 2009
• Last updated: November 12, 2009
• Start date: February 2009
• Est. completion date: October 2009

Study information

• Verified date: November 2009
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis
• Rhinoconjunctivitis

Intervention

Drug:
• Mutaflor
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
• Placebo
1 placebo capsule matching the experimental treatment, according to the experimental arm

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptom-medication score		45 days	No