CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 113 enrolled
Drug / intervention
Lactobacillus rhamnosus HN001 +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01321606
NCT01321606Phase 2Completed
CompareCT.gov

IMpact of PRObiotics for Reducing Infections in VEterans: The IMPROVE Study

VA Office of Research and Development·interventional·Posted Mar 23, 2011·Updated Aug 3, 2018

In Brief

A Phase 2 clinical trial evaluating Lactobacillus rhamnosus HN001 and sugar pill (placebo) for Anti-biotic Resistance. Completed, enrolled 113 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnti-biotic Resistance
CountriesUnited States
CollaboratorsUniversity of Wisconsin, Madison

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 23, 2011
Enrollment StartOct 1, 2011
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 15.3 years ago

Interventions

Lactobacillus rhamnosus HN001dietary

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

sugar pill (placebo)dietary

Placebo identical to the active product will be given