Anti-Infective Agents, Communicable Diseases, Infection, Pharmacologic Actions, Therapeutic Uses
Conditions
Keywords
Probiotics
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis
OTHERPlacebo
Sugar pill
Sponsors
Centers for Disease Control and Prevention
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Probiotic 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 | 44 |
| Sugar Pill Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis
Placebo: Sugar pill | 44 |
| Total | 88 |
Baseline characteristics
| Characteristic | Probiotic | Sugar Pill | Total |
|---|---|---|---|
| Age, Customized Age | 58 years | 60 years | 59 years |
| Race/Ethnicity, Customized Non-white | 20 Participants | 19 Participants | 39 Participants |
| Race/Ethnicity, Customized White | 24 Participants | 25 Participants | 49 Participants |
| Region of Enrollment United States | 44 participants | 44 participants | 88 participants |
| Sex: Female, Male Female | 22 Participants | 20 Participants | 42 Participants |
| Sex: Female, Male Male | 22 Participants | 24 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 44 | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 | 0 / 44 |
Outcome results
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.
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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Probiotic | Number of Participants With Acquisition of Any New Antibiotic-resistant Organism | 9 Participants |
| Sugar Pill | Number of Participants With Acquisition of Any New Antibiotic-resistant Organism | 12 Participants |