search
Back to results

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

Primary Purpose

Rhinoconjunctivitis

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Mutaflor
Placebo
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinoconjunctivitis focused on measuring E.coli, Mutaflor, grass pollen, rhinoconjunctivitis, rhinoconjunctivitis caused by grass pollen

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charité - Universitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Mutaflor

Arm Description

Outcomes

Primary Outcome Measures

symptom-medication score

Secondary Outcome Measures

Full Information

First Posted
November 10, 2009
Last Updated
November 12, 2009
Sponsor
Charite University, Berlin, Germany
search

1. Study Identification

Unique Protocol Identification Number
NCT01013259
Brief Title
Immunomodulation of E.Coli Nissle 1917 in Patients With Grass Pollen Rhinoconjunctivitis
Acronym
Ecorhino
Official Title
Explorative Analysis of the Immunomodulatory Capacities of Apathogenic Escherichia Coli Nissle 1917 in Patients With Rhinoconjunctivitis Due to Grass Pollen Allergy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinoconjunctivitis
Keywords
E.coli, Mutaflor, grass pollen, rhinoconjunctivitis, rhinoconjunctivitis caused by grass pollen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Mutaflor
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Mutaflor
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 placebo capsule matching the experimental treatment, according to the experimental arm
Primary Outcome Measure Information:
Title
symptom-medication score
Time Frame
45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margitta Worm, Prof. Dr. med.
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs