NCT01321606

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

August 3, 2018

Completed
Last Updated

August 3, 2018

Status Verified

November 1, 2017

Enrollment Period

4.2 years

First QC Date

March 21, 2011

Results QC Date

December 8, 2016

Last Update Submit

November 1, 2017

Conditions

Anti-biotic Resistance

Keywords

infectionprobiotics

Outcome Measures

Primary Outcomes (1)

  • Oral L. Rhamnosus HN001 Therapy Compared to Placebo on Gastrointestinal and Extra-gastrointestinal Colonization of S. Aureus.

    Participants in the final outcome may be colonized at both GI and Extra-GI sites, thus the total numbers from the outcome cells can be greater than the overall number of participants analyzed.

    4 weeks

Secondary Outcomes (2)

  • Oral L. Rhamnosus HN001 Therapy Compared With Placebo on Phagocytic Functioning of Polymorphonuclear (PMN) and Monocyte Cells

    4 weeks

  • Oral L. Rhamnosus HN001 Therapy Compared With Placebo on Phagocytic Functioning of Polymorphonuclear (PMN) and Monocyte Cells

    4 weeks

Study Arms (2)

Arm 1: Probiotic

EXPERIMENTAL

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

Arm 2: Placebo

PLACEBO COMPARATOR

Placebo identical to the active product will be given

Dietary Supplement: sugar pill (placebo)

Interventions

Lactobacillus rhamnosus HN001DIETARY_SUPPLEMENT

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

Arm 1: Probiotic
sugar pill (placebo)DIETARY_SUPPLEMENT

Placebo identical to the active product will be given

Arm 2: Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705, United States

Location

Related Publications (2)

  • Eggers S, Barker AK, Valentine S, Hess T, Duster M, Safdar N. Effect of Lactobacillus rhamnosus HN001 on carriage of Staphylococcus aureus: results of the impact of probiotics for reducing infections in veterans (IMPROVE) study. BMC Infect Dis. 2018 Mar 14;18(1):129. doi: 10.1186/s12879-018-3028-6.

    PMID: 29540160DERIVED

  • Eggers S, Barker A, Valentine S, Hess T, Duster M, Safdar N. Impact of Probiotics for Reducing Infections in Veterans (IMPROVE): Study protocol for a double-blind, randomized controlled trial to reduce carriage of Staphylococcus aureus. Contemp Clin Trials. 2017 Jan;52:39-45. doi: 10.1016/j.cct.2016.11.004. Epub 2016 Nov 9.

    PMID: 27836508DERIVED

MeSH Terms

Conditions

Infections

Interventions

Sugars

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

Title
Dr. Nasia Sardar
Organization
William S. Middleton Memorial Veterans Affairs Medical Center
nasia.safdar@va.gov
608-256-1901

Study Officials

  • Nasia Safdar, MD PhD

    William S. Middleton Memorial Veterans Hospital, Madison, WI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2011

First Posted

March 23, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 3, 2018

Results First Posted

August 3, 2018

Record last verified: 2017-11

Locations

US(1)