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The Use of Probiotics to Evaluate Colonization With Antimicrobial Resistant Bacteria

Primary Purpose

Infectious Disease of Digestive Tract

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lactobacillus rhamnosus GG
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infectious Disease of Digestive Tract focused on measuring Probiotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults ≥ 18 years old
  • Admission to the Medical ICU
  • Expected to be on Mechanical Ventilation through an endotracheal tube for >48 hours

Exclusion Criteria:

  • Pregnancy
  • Immunosuppression
  • Prosthetic valve or vascular graft
  • Cardiac trauma
  • Pancreatitis
  • History of rheumatic fever
  • Endocarditis or congenital cardiac abnormality
  • Gastroesophageal or intestinal injury or foregut surgery during the current admission
  • Oropharyngeal mucosal injury
  • Placement of a tracheostomy

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Probiotic

Standard of Care

Arm Description

Patients randomized to probiotic therapy will receive 1 capsule containing 1010 cells of Lactobacillus rhamnosus GG on a twice-daily basis

Patients in the control arm will receive standard care

Outcomes

Primary Outcome Measures

Number of Participants With Combination of Gastrointestinal Tract Colonization With Multi-drug Resistant Gram-negative Bacteria, C. Difficile and VRE
Colonization of the gastrointestinal tract with C. difficile, vancomycin-resistant enterococci, multidrug-resistant Acinetobacter baumannii, and multidrug- resistant Pseudomonas. Colonization occurs when the subject acquires the above organism while in the study.

Secondary Outcome Measures

Full Information

First Posted
March 2, 2012
Last Updated
December 14, 2018
Sponsor
Washington University School of Medicine
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01551186
Brief Title
The Use of Probiotics to Evaluate Colonization With Antimicrobial Resistant Bacteria
Official Title
The Use of the Probiotic, Lactobacillus Rhamnosus GG to Evaluate Colonization With Antimicrobial Resistant Bacteria in High Risk Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 a ventilator.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Disease of Digestive Tract
Keywords
Probiotics

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm Description
Patients randomized to probiotic therapy will receive 1 capsule containing 1010 cells of Lactobacillus rhamnosus GG on a twice-daily basis
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Patients in the control arm will receive standard care
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus rhamnosus GG
Other Intervention Name(s)
Culturelle
Intervention Description
1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis
Primary Outcome Measure Information:
Title
Number of Participants With Combination of Gastrointestinal Tract Colonization With Multi-drug Resistant Gram-negative Bacteria, C. Difficile and VRE
Description
Colonization of the gastrointestinal tract with C. difficile, vancomycin-resistant enterococci, multidrug-resistant Acinetobacter baumannii, and multidrug- resistant Pseudomonas. Colonization occurs when the subject acquires the above organism while in the study.
Time Frame
Participants will be followed while Intubated, an expected average of 7 days. The outcome will be measured 3 days after enrollment and at the end of intubation, average time 7 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults ≥ 18 years old Admission to the Medical ICU Expected to be on Mechanical Ventilation through an endotracheal tube for >48 hours Exclusion Criteria: Pregnancy Immunosuppression Prosthetic valve or vascular graft Cardiac trauma Pancreatitis History of rheumatic fever Endocarditis or congenital cardiac abnormality Gastroesophageal or intestinal injury or foregut surgery during the current admission Oropharyngeal mucosal injury Placement of a tracheostomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria J Fraser, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15699079
Citation
American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.
Results Reference
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PubMed Identifier
15187525
Citation
Kollef MH. Prevention of hospital-associated pneumonia and ventilator-associated pneumonia. Crit Care Med. 2004 Jun;32(6):1396-405. doi: 10.1097/01.ccm.0000128569.09113.fb.
Results Reference
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PubMed Identifier
19179874
Citation
Ruemmele FM, Bier D, Marteau P, Rechkemmer G, Bourdet-Sicard R, Walker WA, Goulet O. Clinical evidence for immunomodulatory effects of probiotic bacteria. J Pediatr Gastroenterol Nutr. 2009 Feb;48(2):126-41. doi: 10.1097/MPG.0b013e31817d80ca.
Results Reference
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PubMed Identifier
19551370
Citation
de Smet AM, Hopmans TE, Minderhoud AL, Blok HE, Gossink-Franssen A, Bernards AT, Bonten MJ. Decontamination of the digestive tract and oropharynx: hospital acquired infections after discharge from the intensive care unit. Intensive Care Med. 2009 Sep;35(9):1609-13. doi: 10.1007/s00134-009-1554-9. Epub 2009 Jun 24.
Results Reference
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PubMed Identifier
19965807
Citation
Oostdijk EA, de Smet AM, Blok HE, Thieme Groen ES, van Asselt GJ, Benus RF, Bernards SA, Frenay IH, Jansz AR, de Jongh BM, Kaan JA, Leverstein-van Hall MA, Mascini EM, Pauw W, Sturm PD, Thijsen SF, Kluytmans JA, Bonten MJ. Ecological effects of selective decontamination on resistant gram-negative bacterial colonization. Am J Respir Crit Care Med. 2010 Mar 1;181(5):452-7. doi: 10.1164/rccm.200908-1210OC. Epub 2009 Dec 3.
Results Reference
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The Use of Probiotics to Evaluate Colonization With Antimicrobial Resistant Bacteria

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