GI Colonization of Vancomycin-resistant EnterococcusNCT00591474

The Influence of Probiotics on Vancomycin-Resistant Enterococcus

A study testing probiotics and yogurt in people with GI Colonization of Vancomycin-resistant Enterococcus, run by Oregon Health and Science University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: GI Colonization of Vancomycin-resistant Enterococcus
What is being tested?: probiotics and yogurt
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 8 participants
Where: 1 siteUnited States
Study dates: Dec 2007to Jun 2010
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

VRE positive patients with GI colonization

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

OHSU hospital
Portland, Oregon, 97239

Other trials in United States

About this study

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).

Conditions: GI Colonization of Vancomycin-resistant Enterococcus
Being tested: probiotics, yogurt
Keywords: VRE, Probiotics, colonization, gut health

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

probioticsDietary supplement
100 gms of a yogurt drink containing probiotics will be given to pVRE positive patients for 4 weeks
yogurtDietary supplement
100 gms of pasteurized yogurt drinks with no live cultures will be given to VRE positive patients for 4 weeks

Study groups in NCT00591474
Study group	Role	What they receive
1	Experimental	VRE positive patients Receives: Dietary Supplement: probiotics
2	Placebo comparator	VRE positive patients Receives: Dietary Supplement: yogurt

What is being measured

The primary outcome is the main question the study is designed to answer.

Whether a positive VRE colonized patient becomes VRE negative after drinking yogurt with probiotics
Measured: 4 weeks

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2007Jun 2010

First posted11 Jan 2008 (estimated)
Study startDec 2007
Primary completionJan 2010
Study completionJun 2010

Why it stopped: Participant lost to followup

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (40)Papers the sponsor has linked to this study.
Other trials for GI Colonization of Vancomycin-resistant EnterococcusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00591474
Sponsor's protocol ID: IRB3848
Status last verified: May 2019
First submitted: 28 Dec 2007
Last updated: 4 Jun 2019
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 16610573
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.
PubMed 15573054
Harbarth S, Cosgrove S, Carmeli Y. Effects of antibiotics on nosocomial epidemiology of vancomycin-resistant enterococci. Antimicrob Agents Chemother. 2002 Jun;46(6):1619-28. doi: 10.1128/AAC.46.6.1619-1628.2002. No abstract available.
PubMed 12019066
Joels CS, Matthews BD, Sigmon LB, Hasan R, Lohr CE, Kercher KW, Norton J, Sing RF, Heniford BT. Clinical characteristics and outcomes of surgical patients with vancomycin-resistant enterococcal infections. Am Surg. 2003 Jun;69(6):514-9.
PubMed 12852510
Pelz RK, Lipsett PA, Swoboda SM, Diener-West M, Powe NR, Brower RG, Perl TM, Hammond JM, Hendrix CW. Vancomycin-sensitive and vancomycin-resistant enterococcal infections in the ICU: attributable costs and outcomes. Intensive Care Med. 2002 Jun;28(6):692-7. doi: 10.1007/s00134-002-1276-8. Epub 2002 Apr 12.
PubMed 12107672
Weinstock DM, Conlon M, Iovino C, Aubrey T, Gudiol C, Riedel E, Young JW, Kiehn TE, Zuccotti G. Colonization, bloodstream infection, and mortality caused by vancomycin-resistant enterococcus early after allogeneic hematopoietic stem cell transplant. Biol Blood Marrow Transplant. 2007 May;13(5):615-21. doi: 10.1016/j.bbmt.2007.01.078. Epub 2007 Mar 23.
PubMed 17448922
Matar MJ, Tarrand J, Raad I, Rolston KV. Colonization and infection with vancomycin-resistant Enterococcus among patients with cancer. Am J Infect Control. 2006 Oct;34(8):534-6. doi: 10.1016/j.ajic.2006.04.205.
PubMed 17015161
Humphreys H, Dolan V, Sexton T, Conlon P, Rajan L, Creamer E, Walshe J, Donohoe J, Smyth EG. Implications of colonization of vancomycin-resistant enterococci (VRE) in renal dialysis patients. Learning to live with it? J Hosp Infect. 2004 Sep;58(1):28-33. doi: 10.1016/j.jhin.2004.04.022.
PubMed 15350710
Zaas AK, Song X, Tucker P, Perl TM. Risk factors for development of vancomycin-resistant enterococcal bloodstream infection in patients with cancer who are colonized with vancomycin-resistant enterococci. Clin Infect Dis. 2002 Nov 15;35(10):1139-46. doi: 10.1086/342904. Epub 2002 Oct 17.
PubMed 12410472
Patel R. Clinical impact of vancomycin-resistant enterococci. J Antimicrob Chemother. 2003 Jun;51 Suppl 3:iii13-21. doi: 10.1093/jac/dkg272.
PubMed 12801938
Kreman T, Hu J, Pottinger J, Herwaldt LA. Survey of long-term-care facilities in Iowa for policies and practices regarding residents with methicillin-resistant Staphylococcus aureus or vancomycin-resistant enterococci. Infect Control Hosp Epidemiol. 2005 Oct;26(10):811-5. doi: 10.1086/502498.
PubMed 16276955
Bryce EA, Tiffin SM, Isaac-Renton JL, Wright CJ. Evidence of delays in transferring patients with methicillin-resistant Staphylococcus aureus or vancomycin-resistant Enterococcus to long-term-care facilities. Infect Control Hosp Epidemiol. 2000 Apr;21(4):270-1. doi: 10.1086/501757.
PubMed 10782590
Baden LR, Thiemke W, Skolnik A, Chambers R, Strymish J, Gold HS, Moellering RC Jr, Eliopoulos GM. Prolonged colonization with vancomycin-resistant Enterococcus faecium in long-term care patients and the significance of "clearance". Clin Infect Dis. 2001 Nov 15;33(10):1654-60. doi: 10.1086/323762. Epub 2001 Oct 10.
PubMed 11595985
Dunne C. Adaptation of bacteria to the intestinal niche: probiotics and gut disorder. Inflamm Bowel Dis. 2001 May;7(2):136-45. doi: 10.1097/00054725-200105000-00010.
PubMed 11383587
Vanderhoof JA, Young RJ. Current and potential uses of probiotics. Ann Allergy Asthma Immunol. 2004 Nov;93(5 Suppl 3):S33-7. doi: 10.1016/s1081-1206(10)61730-9.
PubMed 15562872

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Influence of Probiotics on Vancomycin-Resistant Enterococcus
ClinicalTrials.gov ID: NCT00591474
Acronym / sponsor ID: IRB3848
Conditions: GI Colonization of Vancomycin-resistant Enterococcus
Keywords: VRE, Probiotics, colonization, gut health
Study type: Interventional
Recruitment status: TerminatedReason stopped: Participant lost to followup
Enrolment: 8 participants (actual)
Lead sponsor: Oregon Health and Science UniversityUniversity, hospital or other
Study start: Dec 2007
Primary completion: Jan 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 11 Jan 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Dietary Supplement: probioticsVRE positive patients
2	Placebo comparator	Dietary Supplement: yogurtVRE positive patients

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

VRE positive patients with GI colonization

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
probiotics100 gms of a yogurt drink containing probiotics will be given to pVRE positive patients for 4 weeks	Dietary supplement	1
yogurt100 gms of pasteurized yogurt drinks with no live cultures will be given to VRE positive patients for 4 weeks	Dietary supplement	2

Primary outcome

Whether a positive VRE colonized patient becomes VRE negative after drinking yogurt with probiotics
Time frame: 4 weeks

3 secondary outcomes

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

Results and safety

The study was stopped early (reason given: Participant lost to followup). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
Background: PubMed 16610573Zirakzadeh 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.
Background: PubMed 15573054National 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.
Background: PubMed 12019066Harbarth S, Cosgrove S, Carmeli Y. Effects of antibiotics on nosocomial epidemiology of vancomycin-resistant enterococci. Antimicrob Agents Chemother. 2002 Jun;46(6):1619-28. doi: 10.1128/AAC.46.6.1619-1628.2002. No abstract available.
Background: PubMed 12852510Joels CS, Matthews BD, Sigmon LB, Hasan R, Lohr CE, Kercher KW, Norton J, Sing RF, Heniford BT. Clinical characteristics and outcomes of surgical patients with vancomycin-resistant enterococcal infections. Am Surg. 2003 Jun;69(6):514-9.
Background: PubMed 12107672Pelz RK, Lipsett PA, Swoboda SM, Diener-West M, Powe NR, Brower RG, Perl TM, Hammond JM, Hendrix CW. Vancomycin-sensitive and vancomycin-resistant enterococcal infections in the ICU: attributable costs and outcomes. Intensive Care Med. 2002 Jun;28(6):692-7. doi: 10.1007/s00134-002-1276-8. Epub 2002 Apr 12.
Background: PubMed 17448922Weinstock DM, Conlon M, Iovino C, Aubrey T, Gudiol C, Riedel E, Young JW, Kiehn TE, Zuccotti G. Colonization, bloodstream infection, and mortality caused by vancomycin-resistant enterococcus early after allogeneic hematopoietic stem cell transplant. Biol Blood Marrow Transplant. 2007 May;13(5):615-21. doi: 10.1016/j.bbmt.2007.01.078. Epub 2007 Mar 23.
Background: PubMed 17015161Matar MJ, Tarrand J, Raad I, Rolston KV. Colonization and infection with vancomycin-resistant Enterococcus among patients with cancer. Am J Infect Control. 2006 Oct;34(8):534-6. doi: 10.1016/j.ajic.2006.04.205.
Background: PubMed 15350710Humphreys H, Dolan V, Sexton T, Conlon P, Rajan L, Creamer E, Walshe J, Donohoe J, Smyth EG. Implications of colonization of vancomycin-resistant enterococci (VRE) in renal dialysis patients. Learning to live with it? J Hosp Infect. 2004 Sep;58(1):28-33. doi: 10.1016/j.jhin.2004.04.022.
Background: PubMed 12410472Zaas AK, Song X, Tucker P, Perl TM. Risk factors for development of vancomycin-resistant enterococcal bloodstream infection in patients with cancer who are colonized with vancomycin-resistant enterococci. Clin Infect Dis. 2002 Nov 15;35(10):1139-46. doi: 10.1086/342904. Epub 2002 Oct 17.
Background: PubMed 12801938Patel R. Clinical impact of vancomycin-resistant enterococci. J Antimicrob Chemother. 2003 Jun;51 Suppl 3:iii13-21. doi: 10.1093/jac/dkg272.
Background: PubMed 16276955Kreman T, Hu J, Pottinger J, Herwaldt LA. Survey of long-term-care facilities in Iowa for policies and practices regarding residents with methicillin-resistant Staphylococcus aureus or vancomycin-resistant enterococci. Infect Control Hosp Epidemiol. 2005 Oct;26(10):811-5. doi: 10.1086/502498.
Background: PubMed 10782590Bryce EA, Tiffin SM, Isaac-Renton JL, Wright CJ. Evidence of delays in transferring patients with methicillin-resistant Staphylococcus aureus or vancomycin-resistant Enterococcus to long-term-care facilities. Infect Control Hosp Epidemiol. 2000 Apr;21(4):270-1. doi: 10.1086/501757.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Martindale, MD, PH.D principal investigator

Oregon Health and Science University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing probiotics and yogurt in people with GI Colonization of Vancomycin-resistant Enterococcus, run by Oregon Health and Science University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Participant lost to followup). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Whether a positive VRE colonized patient becomes VRE negative after drinking yogurt with probiotics (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00591474, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.