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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01013259
First Posted: November 13, 2009
Last Update Posted: November 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Charite University, Berlin, Germany
  Purpose
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.

Condition Intervention Phase
Rhinoconjunctivitis Drug: Mutaflor Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Explorative Analysis of the Immunomodulatory Capacities of Apathogenic Escherichia Coli Nissle 1917 in Patients With Rhinoconjunctivitis Due to Grass Pollen Allergy

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • symptom-medication score [ Time Frame: 45 days ]

Enrollment: 34
Study Start Date: February 2009
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
1 placebo capsule matching the experimental treatment, according to the experimental arm
Experimental: Mutaflor 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01013259


Locations
Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Margitta Worm, Prof. Dr. med. Charite University, Berlin, Germany
  More Information

Responsible Party: Prof. Dr. med. Margitta Worm, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01013259     History of Changes
Other Study ID Numbers: Ecorhino
First Submitted: November 10, 2009
First Posted: November 13, 2009
Last Update Posted: November 13, 2009
Last Verified: November 2009

Keywords provided by Charite University, Berlin, Germany:
E.coli
Mutaflor
grass pollen
rhinoconjunctivitis
rhinoconjunctivitis caused by grass pollen

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases