The Use of Probiotics to Evaluate Colonization With Antimicrobial Resistant Bacteria

This study is enrolling participants by invitation only.

Sponsor:

Collaborator:

Centers for Disease Control and Prevention

Information provided by (Responsible Party):

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT01551186

First received: March 2, 2012

Last updated: March 6, 2012

Last verified: March 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Infectious Disease of Digestive Tract	Dietary Supplement: Lactobacillus rhamnosus GG	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	The Use of the Probiotic, Lactobacillus Rhamnosus GG to Evaluate Colonization With Antimicrobial Resistant Bacteria in High Risk Patients

Resource links provided by NLM:

Drug Information available for: Lactobacillus

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

Combination of gastrointestinal tract colonization with multi-drug resistant gram-negative bacteria, C. difficile and VRE [ 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) ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	72
Study Start Date:	February 2012
Estimated Study Completion Date:	March 2016
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Probiotic Patients randomized to probiotic therapy will receive 1 capsule containing 1010 cells of Lactobacillus rhamnosus GG on a twice-daily basis	Dietary Supplement: Lactobacillus rhamnosus GG 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis Other Name: Culturelle
No Intervention: Standard of Care Patients in the control arm will receive standard care

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551186

Locations

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Centers for Disease Control and Prevention

Investigators

Principal Investigator:

Victoria J Fraser, MD

Washington University School of Medicine

More Information

Publications:

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. No abstract available.

Kollef MH. Prevention of hospital-associated pneumonia and ventilator-associated pneumonia. Crit Care Med. 2004 Jun;32(6):1396-405. Review.

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. Review.

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. Epub 2009 Jun 24.

Oostdijk EA, de Smet AM, Blok HE, Thieme Groen ES, van Asselt GJ, Benus RF, Bernards SA, Frénay 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. Epub 2009 Dec 3.

Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT01551186 History of Changes
Other Study ID Numbers:	201106182, 1U54CK000162
Study First Received:	March 2, 2012
Last Updated:	March 6, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

Probiotics

Additional relevant MeSH terms:

Communicable Diseases
Infection
Intestinal Diseases
Gastrointestinal Diseases

Digestive System Diseases
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013

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