- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01013259
Immunomodulation of E.Coli Nissle 1917 in Patients With Grass Pollen Rhinoconjunctivitis (Ecorhino)
November 12, 2009 updated by: Charite University, Berlin, Germany
Explorative Analysis of the Immunomodulatory Capacities of Apathogenic Escherichia Coli Nissle 1917 in Patients With Rhinoconjunctivitis Due to Grass Pollen Allergy
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin, Germany, 10117
- Charité - Universitätsmedizin Berlin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
1 placebo capsule matching the experimental treatment, according to the experimental arm
|
Experimental: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
symptom-medication score
Time Frame: 45 days
|
45 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Margitta Worm, Prof. Dr. med., Charite University, Berlin, Germany
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
November 10, 2009
First Submitted That Met QC Criteria
November 12, 2009
First Posted (Estimate)
November 13, 2009
Study Record Updates
Last Update Posted (Estimate)
November 13, 2009
Last Update Submitted That Met QC Criteria
November 12, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ecorhino
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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