Phase 4
N=103
The Use of Probiotics to Evaluate Colonization With Antimicrobial Resistant Bacteria
Infectious Disease of Digestive Tract
Bottom Line
View on ClinicalTrials.gov: NCT01551186 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Number of Participants With Combination of Gastrointestinal Tract Colonization With Multi-drug Resistant Gram-negative Bacteria, C. Difficile and VRE — 8; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lactobacillus rhamnosus GG (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Combination of Gastrointestinal Tract Colonization With Multi-drug Resistant Gram-negative Bacteria, C. Difficile and VRE |
8; 8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adults ≥ 18 years old
- Admission to the Medical ICU
- Expected to be on Mechanical Ventilation through an endotracheal tube for >48 hours
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01551186). 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.