Removal of intestinal colonization with bacteria resistant to many antimicrobial agents by ingestion of a probiotic substance
- Conditions
- Intestinal colonisation with multiresistant bacteriaMedDRA version: 14.1Level: LLTClassification code 10069719Term: Bacterial colonisationSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2011-005833-38-AT
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Age = 18 years
Stool culture positive for ESBL producing Enterobacteriacea or vancomycin resistant enterococci
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
Exclusion Criteria
a) Immunosuppression
b) Transplanted patients
c) Neutropenic patients
d) Patients who received biological medication, especially TNF-a inhibitors, in the past twelve months prior to inclusion
e) Known pregnancy
f) allergy to milk protein
g) Other reasons opposing the study participation on the discretion of the investigators.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method