Impact of Probiotics for Reducing Infections in Veterans: The IMPROVE Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Department of Veterans Affairs
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01321606
First received: March 21, 2011
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

We have two hypotheses: (1) The probiotic L. rhamnosus HN001, when compared to placebo, will reduce S. aureus nasal colonization when taken for four weeks. (2) The probiotic L. rhamnosus HN001, when compared to placebo, will reduce S. aureus gastrointestinal colonization when taken for four weeks.


Condition Intervention Phase
Anti-biotic Resistance
Dietary Supplement: Lactobacillus rhamnosus HN001
Dietary Supplement: sugar pill (placebo)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: IMpact of PRObiotics for Reducing Infections in VEterans: The IMPROVE Study

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • To determine the effect of 4 weeks of oral L. rhamnosus HN001 therapy compared with placebo on nasal and gastrointestinal colonization of S. aureus when compared to placebo [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the effect of 4 weeks of oral L. rhamnosus HN001 therapy on phagocytic functioning of polymorphonuclear (PMN) and monocyte cells [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 114
Study Start Date: October 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
subjects will be given a capsule formulation of a 1x10^10 colony-forming units of probiotic L. rhamnosus HN001 to be taken once a day, for 4 weeks
Dietary Supplement: Lactobacillus rhamnosus HN001
Subjects will be given a pill formulation of a probiotic L. rhamnosus HN001 to be taken once a day, at a dose of 1 x 10^10 organisms
Other Name: Lactobacillus rhamnosus HN001
Placebo Comparator: Arm 2
Placebo identical to the active product will be given
Dietary Supplement: sugar pill (placebo)
Placebo identical to the active product will be given

Detailed Description:

Reducing infections caused by S. aureus is essential. The knowledge that colonization at a few key body sites such as the nose and the gastrointestinal tract is a prerequisite for infection2 ,3 offers an opportunity for therapeutic intervention. Thirty percent of the population has nasal colonization with S. aureus. In the last few years, decolonization agents such as mupirocin topical ointment and oral antibiotics such as doxycycline and rifampin have been studied for their utility in reducing colonization. However, these options have limitations in that recolonization is common, the impact of these interventions on multiple sites of colonization has not been assessed and resistance develops frequently to any of these, especially the oral antibiotics. Resistance in S. aureus has been designated a public health crisis. Methicillin-resistant S. aureus (MRSA) now accounts for 60% of all S. aureus infections. As an example of the growing crisis in S. aureus resistance, it should be noted that the number of MRSA infections rose from 2000 in 1993 to 368,000 in 2005. MRSA infections pose an even greater health and economic burden on the population than those caused by methicillin-sensitive S. aureus.4-8 S. aureus and MRSA infection trends in the VA health system mirror national trends5 and are associated with considerable morbidity and mortality in veterans. A treatment that reduces S. aureus and MRSA colonization, without a risk of promoting antibiotic resistance could represent a breakthrough in decolonization therapy. Probiotics may be one such treatment option.

Probiotics are live microorganisms that are available over the counter, widely used as dietary supplements or nutritional foods and represent a low-cost, well tolerated, safe, non-antibiotic based strategy that may have efficacy for decolonization without the attendant risks of promoting antimicrobial resistance.9 Certain probiotics, including Lactobacillus rhamnosus HN001, have demonstrated ability to stimulate systemic immune functions, possibly enhancing the body's ability to eradicate S. aureus in the gastrointestinal tract and at sites remote from the gastrointestinal tract such as the nose.10 ,11 The long-term goal of our research is to identify and test novel interventions for reducing infections caused by resistant bacteria. We propose a Phase II randomized, double-blind, placebo-controlled clinical trial in veterans to evaluate the efficacy of an oral probiotic, Lactobacillus rhamnosus HN001, for reducing S. aureus colonization. This study will produce data, methods, and tools that have widespread relevance and portability, with the potential to reduce healthcare-associated infections.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Colonized at nasal or gastrointestinal source by S. aureus including MRSA
  • Age 18 years or older
  • Able to take oral medications
  • Able to provide informed consent

Exclusion Criteria:

Uncontrolled psychiatric illness

  • On a decolonization protocol for MRSA (e.g mupirocin, tea tree oil)
  • Current involvement in another investigational trial
  • Pregnancy
  • Persistent diarrhea (> 3 loose stools per day for at least 2 days)
  • Active infection with S.aureus or MRSA
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321606

Contacts
Contact: Nasia Safdar, MD PhD (608) 280-7007 Nasia.Safdar@va.gov
Contact: Susan K Valentine, RN MS (608) 256-1901 ext 17535 susan.valentine@va.gov

Locations
United States, Wisconsin
William S. Middleton Memorial Veterans Hospital, Madison, WI Recruiting
Madison, Wisconsin, United States, 53705
Contact: Nasia Safdar, MD PhD    608-280-7007    Nasia.Safdar@va.gov   
Contact: Susan K Valentine, RN MS    (608) 256-1901 ext 17535    susan.valentine@va.gov   
Principal Investigator: Nasia Safdar, MD PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Nasia Safdar, MD PhD William S. Middleton Memorial Veterans Hospital, Madison, WI
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01321606     History of Changes
Other Study ID Numbers: CLIN-010-10S, OMB 4040-0001
Study First Received: March 21, 2011
Last Updated: August 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
infection
probiotics

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on September 15, 2014