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

NCT ID: NCT01013259

Last Updated: 2009-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2009-10-31

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.

Conditions

Rhinoconjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Mutaflor

Group Type: EXPERIMENTAL

Mutaflor

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Charite University, Berlin, Germany

Principal Investigators

Margitta Worm, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Countries

Germany

Other Identifiers

Ecorhino

Identifier Type: -

Identifier Source: org_study_id