NCT02046512

Brief Summary

The purpose of this study is to evaluate the effectiveness of bacteria called Lactobacillus GG, a Probiotic, in preventing the growth of resistant bacteria in the digestive tract in patients on broad spectrum antimicrobials.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_4

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

Study Start

First participant enrolled

January 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

April 4, 2022

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

1.7 years

First QC Date

January 23, 2014

Results QC Date

January 26, 2022

Last Update Submit

March 29, 2022

Conditions

Communicable DiseasesInfectionAnti-Infective AgentsTherapeutic UsesPharmacologic Actions

Keywords

Probiotics

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Acquisition of Any New Antibiotic-resistant Organism

    Acquisition in the gastrointestinal tract of any new antibiotic resistant organism post-enrollment. Antibiotic resistant organisms include: C. difficile, vancomycin-resistant enterococci (VRE), multidrug-resistant Acinetobacter baumannii, multidrug-resistant Pseudomonas, ciprofloxacin-resistant Enterobacteriaceae, extended-spectrum betalactamase (ESBL) producing Enterobacteriaceae.

    Outcome will be measured approximately every 3 days after enrollment throughout hospitalization, and at the time of discharge (the median duration of hospitalization was 13.5 days).

Study Arms (2)

Probiotic

EXPERIMENTAL

Patients randomized to probiotic therapy will receive 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis

Dietary Supplement: Probiotic

Sugar Pill

PLACEBO COMPARATOR

Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis

Other: Placebo

Interventions

ProbioticDIETARY_SUPPLEMENT

1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis

Also known as: Culturelle
Probiotic
PlaceboOTHER

Sugar pill

Sugar Pill

Eligibility Criteria

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

You may qualify if:

  • Adults ≥ 18 years old
  • Admission to the non-ICU medical and surgical wards
  • On broad spectrum antimicrobials with an anticipated length of stay of \>48 hours

You may not qualify if:

  • Pregnancy
  • Non English speaking
  • Expected to die within 7 days
  • Unable or unwilling to consent
  • HIV infection with a CD4 count \<200
  • Neutropenia with an absolute neutrophil count less than 500 cells/ml (or expected to drop to less than 500)
  • Clinically significant diarrhea or history of C. difficile infection in the last 3 months
  • History of VRE colonization and/or infection in the last year
  • Transplant recipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (10)

  • Lucado J, Gould C, Elixhauser A. Clostridium Difficile Infections (CDI) in Hospital Stays, 2009. 2012 Jan. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #124. Available from http://www.ncbi.nlm.nih.gov/books/NBK92613/

    PMID: 22574332BACKGROUND

  • Hall AJ, Curns AT, McDonald LC, Parashar UD, Lopman BA. The roles of Clostridium difficile and norovirus among gastroenteritis-associated deaths in the United States, 1999-2007. Clin Infect Dis. 2012 Jul;55(2):216-23. doi: 10.1093/cid/cis386. Epub 2012 Apr 4.

    PMID: 22491338BACKGROUND

  • Yahav D, Lador A, Paul M, Leibovici L. Efficacy and safety of tigecycline: a systematic review and meta-analysis. J Antimicrob Chemother. 2011 Sep;66(9):1963-71. doi: 10.1093/jac/dkr242. Epub 2011 Jun 18.

    PMID: 21685488BACKGROUND

  • Kelesidis T, Humphries R, Uslan DZ, Pegues DA. Daptomycin nonsusceptible enterococci: an emerging challenge for clinicians. Clin Infect Dis. 2011 Jan 15;52(2):228-34. doi: 10.1093/cid/ciq113.

    PMID: 21288849BACKGROUND

  • Infectious Diseases Society of America (IDSA); Spellberg B, Blaser M, Guidos RJ, Boucher HW, Bradley JS, Eisenstein BI, Gerding D, Lynfield R, Reller LB, Rex J, Schwartz D, Septimus E, Tenover FC, Gilbert DN. Combating antimicrobial resistance: policy recommendations to save lives. Clin Infect Dis. 2011 May;52 Suppl 5(Suppl 5):S397-428. doi: 10.1093/cid/cir153. No abstract available.

    PMID: 21474585BACKGROUND

  • Centers for Disease Control and Prevention (CDC). Vital signs: carbapenem-resistant Enterobacteriaceae. MMWR Morb Mortal Wkly Rep. 2013 Mar 8;62(9):165-70.

    PMID: 23466435BACKGROUND

  • Morrow LE, Kollef MH, Casale TB. Probiotic prophylaxis of ventilator-associated pneumonia: a blinded, randomized, controlled trial. Am J Respir Crit Care Med. 2010 Oct 15;182(8):1058-64. doi: 10.1164/rccm.200912-1853OC. Epub 2010 Jun 3.

    PMID: 20522788BACKGROUND

  • Goldenberg JZ, Ma SS, Saxton JD, Martzen MR, Vandvik PO, Thorlund K, Guyatt GH, Johnston BC. Probiotics for the prevention of Clostridium difficile-associated diarrhea in adults and children. Cochrane Database Syst Rev. 2013 May 31;(5):CD006095. doi: 10.1002/14651858.CD006095.pub3.

    PMID: 23728658BACKGROUND

  • Johnston BC, Ma SS, Goldenberg JZ, Thorlund K, Vandvik PO, Loeb M, Guyatt GH. Probiotics for the prevention of Clostridium difficile-associated diarrhea: a systematic review and meta-analysis. Ann Intern Med. 2012 Dec 18;157(12):878-88. doi: 10.7326/0003-4819-157-12-201212180-00563.

    PMID: 23362517BACKGROUND

  • Hink T, Burnham CA, Dubberke ER. A systematic evaluation of methods to optimize culture-based recovery of Clostridium difficile from stool specimens. Anaerobe. 2013 Feb;19:39-43. doi: 10.1016/j.anaerobe.2012.12.001. Epub 2012 Dec 13.

    PMID: 23247066BACKGROUND

MeSH Terms

Conditions

Communicable DiseasesInfections

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Kimberly Reske, Research Coordinator
Organization
Washington University in St. Louis School of Medicine
kreske@wustl.edu
3147474041

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2014

First Posted

January 27, 2014

Study Start

January 1, 2014

Primary Completion

October 1, 2015

Study Completion

December 1, 2018

Last Updated

April 4, 2022

Results First Posted

April 4, 2022

Record last verified: 2022-03

Locations

US(1)