The Use of Probiotics to Evaluate Colonization With Antimicrobial Resistant Bacteria

NCT01551186 | Completed Phase 4 Results

• 2 other identifiers: 2011061821U54CK000162
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Infectious Disease of Digestive Tract

Keywords

Probiotics

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

Study Arms (2)

Probiotic

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

Patients in the control arm will receive standard care

Interventions

Lactobacillus rhamnosus GG DIETARY_SUPPLEMENT

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

Also known as: Culturelle

Probiotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (5)

• 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.

  PMID: 15699079 BACKGROUND

• 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.

  PMID: 15187525 BACKGROUND

• 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.

  PMID: 19179874 BACKGROUND

• 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.

  PMID: 19551370 BACKGROUND

• 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.

  PMID: 19965807 BACKGROUND

Results Point of Contact

• Title: Dr. Erik Dubberke, MD, MSPH
• Organization: Washington University School of Medicine, St. Louis, Missouri

edubberk@wustl.edu

314-454-8354

Study Officials

• Victoria J Fraser, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2012
• First Posted: March 12, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 17, 2018
• Results First Posted: December 17, 2018

Record last verified: 2018-12

Locations

US (1)