Phase 2
Completed N=113
Impact of Probiotics for Reducing Infections in Veterans: The IMPROVE Study
Anti-biotic Resistance
Source: ClinicalTrials.gov NCT01321606 ↗
Enrolled (actual)
113
Serious AEs
1.8%
Results posted
Aug 2018
Primary outcomePrimary: Oral L. Rhamnosus HN001 Therapy Compared to Placebo on Gastrointestinal and Extra-gastrointestinal Colonization of S. Aureus. — 9; 17; 25; 24 Participants
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.
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 | — |
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. Informational only — not medical advice.