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

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.

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Key information

Conditions

Rhinoconjunctivitis Bacterial Infections Bacterial Infections and Mycoses Enterobacteriaceae Infections Escherichia coli Infections Gram-Negative Bacterial Infections Infections

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mutaflor

Drug

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

Placebo

Drug

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

Primary outcomes

symptom-medication score

Time frame: 45 days

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Explorative Analysis of the Immunomodulatory Capacities of Apathogenic Escherichia Coli Nissle 1917 in Patients With Rhinoconjunctivitis Due to Grass Pollen Allergy

Acronym: Ecorhino

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Nov 13, 2009
Registry last updated: Nov 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed