Phase 2
N=113
Impact of Probiotics for Reducing Infections in Veterans: The IMPROVE Study
Anti-biotic Resistance
Bottom Line
View on ClinicalTrials.gov: NCT01321606 ↗Enrolled (actual)
113
Serious AEs
1.8%
Results posted
Aug 2018
Primary outcome: Primary: Oral L. Rhamnosus HN001 Therapy Compared to Placebo on Gastrointestinal and Extra-gastrointestinal Colonization of S. Aureus. — 9; 17; 25; 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lactobacillus rhamnosus HN001 (Dietary_supplement); sugar pill (placebo) (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oral L. Rhamnosus HN001 Therapy Compared to Placebo on Gastrointestinal and Extra-gastrointestinal Colonization of S. Aureus. |
9; 17; 25; 24; 16; 22 | — |
| SECONDARY Oral L. Rhamnosus HN001 Therapy Compared With Placebo on Phagocytic Functioning of Polymorphonuclear (PMN) and Monocyte Cells |
-0.54; 0.59; 0.07; 0.15 | — |
| SECONDARY Oral L. Rhamnosus HN001 Therapy Compared With Placebo on Phagocytic Functioning of Polymorphonuclear (PMN) and Monocyte Cells |
-0.54; 0.59; 0.07; 0.15 | — |
Summary
The investigators 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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01321606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.