Immunomodulation of E.Coli Nissle 1917 in Patients With G... | NCT01013259

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

NCT01013259

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Nov 13, 2009Estimated

Enrollment

34Actual

Phase

Phase 2

Conditions

Rhinoconjunctivitis

Interventions

Mutaflor
Placebo

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Sep 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Nov 10, 2009

First Submission Date that Met QC Criteria

Nov 12, 2009

First Posted Date

Nov 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2009

Last Update Posted Date

Nov 13, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
Mutaflor	Experimental		Drug: Mutaflor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Measure	Description	Time Frame
symptom-medication score		45 days

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Margitta Worm, Prof. Dr. med.	Charite University, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité - Universitätsmedizin Berlin		Berlin		10117	Germany

Condition Browse Module

MeSH Terms

ID	Term
D004927	Escherichia coli Infections

Ancestor Terms

ID	Term
D004756	Enterobacteriaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided