Clinical trial NCT01551186: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infectious Disease of Digestive Tract
Keywords: Probiotics
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2012-03-12
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Number of Participants With Combination of Gastrointestinal Tract Colonization With Multi-drug Resistant Gram-negative Bacteria, C. Difficile and VRE
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Victoria J Fraser, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.