Phase 4
N=89
Probiotics to Promote Intestinal Health
Communicable Diseases · Infection · Anti-Infective Agents · Therapeutic Uses · Pharmacologic Actions
Bottom Line
View on ClinicalTrials.gov: NCT02046512 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Number of Participants With Acquisition of Any New Antibiotic-resistant Organism — 9; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Probiotic (Dietary_supplement); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Acquisition of Any New Antibiotic-resistant Organism |
9; 12 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02046512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.