The Influence of Probiotics on Vancomycin-Resistant Enter... | NCT00591474

Studies
The Influence of Probiotics on Vancomycin-Resistant Enterococcus

NCT00591474

Sponsor

Oregon Health and Science University

Status

Terminated

Last Update Posted

Jun 4, 2019Actual

Enrollment

8Actual

Phase

Not Applicable

Conditions

GI Colonization of Vancomycin-resistant Enterococcus

Interventions

probiotics
yogurt

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Participant lost to followup

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Jan 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Dec 28, 2007

First Submission Date that Met QC Criteria

Jan 10, 2008

First Posted Date

Jan 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2019

Last Update Posted Date

Jun 4, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Robert Martindale, MD, PhD, Oregon Health and Science UniversityPrincipal Investigator

Lead Sponsor

Oregon Health and Science UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Drinking probiotics in a the form of a yogurt drink will restore normal gastrointestinal (GI) bacteria in patients whose colon are colonized with vancomycin-resistant enterococcus (VRE).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	VRE positive patients	Dietary Supplement: probiotics
2	Placebo Comparator	VRE positive patients	Dietary Supplement: yogurt

Interventions

Name	Type	Description	Arm Group Labels	Other Names
probiotics	Dietary Supplement	100 gms of a yogurt drink containing probiotics will be given to pVRE positive patients for 4 weeks	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Whether a positive VRE colonized patient becomes VRE negative after drinking yogurt with probiotics		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Time to VRE clearance		4 weeks
Sustainable effects of probiotics on VRE colonization		8 weeks
Any positive or negative effects on patients' hospital stay.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

VRE positive patients with GI colonization

Exclusion Criteria:

Age less than 18 years
Patients who have had a bone marrow transplant
Extreme short bowel patients (less than 100 cm small bowel remaining)
Patients with active VRE infection but no GI colonization
Patients unable to eat and have no feeding access
Patients who do not have a power of attorney to give consent if they are unable to

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Martindale, MD, PH.D	Oregon Health and Science University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OHSU hospital		Portland	Oregon	97239	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16610573	Background	Zirakzadeh A, Patel R. Vancomycin-resistant enterococci: colonization, infection, detection, and treatment. Mayo Clin Proc. 2006 Apr;81(4):529-36. doi: 10.4065/81.4.529.
15573054	Background	National Nosocomial Infections Surveillance System. National Nosocomial Infections Surveillance (NNIS) System Report, data summary from January 1992 through June 2004, issued October 2004. Am J Infect Control. 2004 Dec;32(8):470-85. doi: 10.1016/S0196655304005425. No abstract available.

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

ID	Term
D019936	Probiotics
D015014	Yogurt