NCT01013259

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed
Last Updated

November 13, 2009

Status Verified

November 1, 2009

Enrollment Period

7 months

First QC Date

November 10, 2009

Last Update Submit

November 12, 2009

Conditions

Rhinoconjunctivitis

Keywords

E.coliMutaflorgrass pollenrhinoconjunctivitisrhinoconjunctivitis caused by grass pollen

Outcome Measures

Primary Outcomes (1)

  • symptom-medication score

    45 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Mutaflor

EXPERIMENTAL
Drug: Mutaflor

Interventions

MutaflorDRUG

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

Mutaflor
PlaceboDRUG

1 placebo capsule matching the experimental treatment, according to the experimental arm

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • perennial rhinoconjunctivitis
  • sinusitis
  • chronic diarrhoea and other existing severe gastrointestinal diseases
  • current specific immunotherapy to grass pollen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Escherichia coli Infections

Condition Hierarchy (Ancestors)

Enterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Margitta Worm, Prof. Dr. med.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 10, 2009

First Posted

November 13, 2009

Study Start

February 1, 2009

Primary Completion

September 1, 2009

Study Completion

October 1, 2009

Last Updated

November 13, 2009

Record last verified: 2009-11

Locations

DE(1)