This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Charite University, Berlin, Germany Identifier:
First received: November 10, 2009
Last updated: November 12, 2009
Last verified: November 2009
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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01013259

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

Responsible Party: Prof. Dr. med. Margitta Worm, Charite University, Berlin, Germany Identifier: NCT01013259     History of Changes
Other Study ID Numbers: Ecorhino
Study First Received: November 10, 2009
Last Updated: November 12, 2009

Keywords provided by Charite University, Berlin, Germany:
grass pollen
rhinoconjunctivitis caused by grass pollen

Additional relevant MeSH terms:
Conjunctival Diseases
Eye Diseases processed this record on August 18, 2017