Probiotics to Promote Intestinal Health
Study Details
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 broad spectrum antimicrobials.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Probiotic Patients randomized to probiotic therapy will receive 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis |
Dietary Supplement: Probiotic
1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis
Other Names:
|
Placebo Comparator: Sugar Pill Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis |
Other: Placebo
Sugar pill
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Acquisition of Any New Antibiotic-resistant Organism [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).]
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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
- Centers for Disease Control and Prevention
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Centers for Disease Control and Prevention (CDC). Vital signs: carbapenem-resistant Enterobacteriaceae. MMWR Morb Mortal Wkly Rep. 2013 Mar 8;62(9):165-70.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Lucado J, Gould C, Elixhauser A. Clostridium Difficile Infections (CDI) in Hospital Stays, 2009. 2012 Jan. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #124. Available from http://www.ncbi.nlm.nih.gov/books/NBK92613/
- 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.
- 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.
- 201310102
- CK000162-aim3
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Probiotic | Sugar Pill |
---|---|---|
Arm/Group Description | Patients randomized to probiotic therapy will receive 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis Probiotic: 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis | Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis Placebo: Sugar pill |
Period Title: Overall Study | ||
STARTED | 45 | 44 |
COMPLETED | 44 | 44 |
NOT COMPLETED | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Probiotic | Sugar Pill | Total |
---|---|---|---|
Arm/Group Description | Patients randomized to probiotic therapy will receive 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis Probiotic: 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis | Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis Placebo: Sugar pill | Total of all reporting groups |
Overall Participants | 44 | 44 | 88 |
Age, Customized (years) [Median (Full Range) ] | |||
Age |
58
|
60
|
59
|
Sex: Female, Male (Count of Participants) | |||
Female |
22
50%
|
20
45.5%
|
42
47.7%
|
Male |
22
50%
|
24
54.5%
|
46
52.3%
|
Race/Ethnicity, Customized (Count of Participants) | |||
White |
24
54.5%
|
25
56.8%
|
49
55.7%
|
Non-white |
20
45.5%
|
19
43.2%
|
39
44.3%
|
Region of Enrollment (participants) [Number] | |||
United States |
44
100%
|
44
100%
|
88
100%
|
Outcome Measures
Title | Number of Participants With Acquisition of Any New Antibiotic-resistant Organism |
---|---|
Description | 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. |
Time Frame | 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). |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Probiotic | Sugar Pill |
---|---|---|
Arm/Group Description | Patients randomized to probiotic therapy will receive 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis Probiotic: 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis | Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis Placebo: Sugar pill |
Measure Participants | 44 | 44 |
Count of Participants [Participants] |
9
20.5%
|
12
27.3%
|
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Probiotic | Sugar Pill | ||
Arm/Group Description | Patients randomized to probiotic therapy will receive 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis Probiotic: 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis | Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis Placebo: Sugar pill | ||
All Cause Mortality |
||||
Probiotic | Sugar Pill | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Probiotic | Sugar Pill | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/44 (0%) | 0/44 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Probiotic | Sugar Pill | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/44 (0%) | 0/44 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Kimberly Reske, Research Coordinator |
---|---|
Organization | Washington University in St. Louis School of Medicine |
Phone | 3147474041 |
kreske@wustl.edu |
- 201310102
- CK000162-aim3