Probiotics to Promote Intestinal Health

Infection Clinical Trial

Official title:

Randomized Controlled Trial of Lactobacillus Rhamnosus GG to Promote Intestinal Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046512
• Other study ID #: 201310102
• Secondary ID: CK000162-aim3
• Status: Completed
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: December 2018

Study information

• Verified date: March 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 2018
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anti-Infective Agents
• Communicable Diseases
• Infection
• Infections
• Pharmacologic Actions
• Therapeutic Uses

Intervention

Dietary Supplement:
• Probiotic
1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis

Other:
• Placebo
Sugar pill

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (10)

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

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. Review. Update in: Cochrane Database Syst Rev. 2017 Dec 19;12 :CD006095. — View Citation

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. — View Citation

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. — View Citation

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:S397-428. doi: 10.1093/cid/cir153. — View Citation

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. Review. — View Citation

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. — View Citation

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

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).