- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01112995
A Pilot Trial to Determine the Efficacy of Lactobacillus Rhamnosus for Reducing Colonization by Methicillin-resistant Staphylococcus Aureus (MRSA) (PROSE) (PROSE)
A Pilot Randomized Trial to Determine the Efficacy of a Probiotic, Lactobacillus Rhamnosus for Reducing Colonization by Methicillin-resistant Staphylococcus Aureus (MRSA)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Healthcare-associated infections are an important threat to patient safety. Currently, between 5 and 10 percent of patients admitted to acute care hospitals acquire one or more infections; healthcare-associated infections affect approximately 2 million patients each year in the United States, result in 90,000 deaths, and are associated with an added cost of $4.5 to $5.7 billion per year. Seventy percent of healthcare-associated infections are caused by antimicrobial resistant bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA), resulting in increased antimicrobial usage, morbidity and mortality, making prevention of multiresistant bacteria essential.
Eradication of colonization has been shown to greatly reduce infection; however, there are no reliable means of providing sustained eradication of colonization. No effective means of eradicating MRSA colonization exist.
Probiotics containing strains of lactobacilli represent a novel approach to the prevention and control of antimicrobial resistance and have been studied extensively for a variety of infections. Even though various studies have shown probiotics to be effective for prevention of vaginal infections, urinary tract infections, etc no studies have examined the potential of probiotics to eradicate colonization by resistant pathogens, such as MRSA.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- subjects will be male or female
- 18 years of age or older
- may or may not be hospitalized
- able to take oral medications
- have been found to be colonized with MRSA or at high risk of being colonized by MRSA and are not taking antibiotics
Exclusion Criteria:
- people on antibiotics will not be eligible to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Probiotic
subjects will be given a pill formulation of a probiotic Lactobacillus rhamnosus to be taken once a day.
|
1 pill formulation to be given once a day for 4 weeks
Other Names:
|
Placebo Comparator: Sugar pill
placebo identical to the active product will be given
|
placebo identical to the active product will be given
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The main outcomes will be the proportion of patients colonized with MRSA at 4 weeks, 8 weeks, 12 weeks and 24 weeks following start of treatment.
Time Frame: 24 weeks
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of clinical infections will be assessed in the one year following enrollment into the study
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nasia Safdar, MD, Ph.D, University of Wisconsin Department of Medicine (Infectious Disease)
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-0023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infection
-
West Virginia UniversityEnrolling by invitationSkin and Soft Tissue Infection | Gastrointestinal Infection | Pulmonary Infection | Bone and Joint Infection | Endovascular Infection | Genitourinary InfectionUnited States
-
Ondine Biomedical Inc.CompletedSurgical Site Infection | Nosocomial Infection | Healthcare Associated InfectionUnited States
-
Gundersen Lutheran Medical FoundationGundersen Lutheran Health SystemCompletedSurgical Site Infection | Superficial Surgical Site Infection | Deep Surgical Site Infection | Organ/Space Surgical Site InfectionUnited States
-
Croydon Health Services NHS TrustCompletedSurgical Site Infection | Wound Infection | Cesarean Section; Infection | Perineal InfectionUnited Kingdom
-
Cairo UniversityRecruitingPostoperative Infection | Cesarean Section Complications | Vaginal InfectionEgypt
-
Vastra Gotaland RegionGöteborg UniversityRecruitingProsthetic Joint Infection | Hip Prosthesis Infection | Prosthetic Infection | Knee Prosthesis InfectionSweden
-
Duke UniversityAgency for Healthcare Research and Quality (AHRQ)CompletedSurgical Site Infection | Infection ControlUnited States
-
University of ZurichRecruitingProsthetic Joint Infection | Surgical Site Infection | Prosthesis and Implants | Postoperative Wound Infection Deep Incisional Surgical SiteSwitzerland
-
Ondine Biomedical Inc.CompletedNosocomial Infection | Surgical Site Infections | Healthcare Associated InfectionsUnited States
-
Leiden University Medical CenterRadboud University Medical Center; University Medical Center Groningen; Erasmus... and other collaboratorsRecruitingProsthetic-joint Infection | Infection Hip | Infection; Knee, JointNetherlands
Clinical Trials on Lactobacillus rhamnosus
-
Duke UniversityCompletedMicrobiomeUnited States
-
Azienda Ospedaliero, Universitaria PisanaCompleted
-
VU University of AmsterdamYoba for Life FoundationUnknownSkin Diseases | Respiratory Tract Infections | DiarrheaUganda
-
VU University of AmsterdamYoba for Life FoundationCompletedSkin Diseases | Respiratory Tract Infections | Diarrhea | Common Cold | Tinea CapitisUganda
-
Groningen Research Institute for Asthma and COPDNumico Research Wageningen, the NetherlandsCompletedAtopic Dermatitis | Atopic Eczema | Infantile EczemaNetherlands
-
Pablo Román LópezCompleted
-
Medical University of WarsawAdamed Pharma S.A.Not yet recruitingAntibiotic-associated DiarrheaPoland
-
Western University, CanadaNational Institute for Medical Research, TanzaniaCompleted
-
Valio LtdUniversity of Virginia; University of Helsinki; Medcare LtdCompletedRespiratory Tract Infections [C08.730]United States
-
Rigshospitalet, DenmarkCompleted