Infectious Disease of Digestive Tract
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 a ventilator.
Interventions
DIETARY_SUPPLEMENTLactobacillus rhamnosus GG
1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis
Sponsors
Centers for Disease Control and Prevention
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Combination of Gastrointestinal Tract Colonization With Multi-drug Resistant Gram-negative Bacteria, C. Difficile and VRE | Participants will be followed while Intubated, an expected average of 7 days. The outcome will be measured 3 days after enrollment and at the end of intubation, average time 7 days) | Colonization of the gastrointestinal tract with C. difficile, vancomycin-resistant enterococci, multidrug-resistant Acinetobacter baumannii, and multidrug- resistant Pseudomonas. Colonization occurs when the subject acquires the above organism while in the study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Probiotic Patients randomized to probiotic therapy will receive 1 capsule containing 1010 cells of Lactobacillus rhamnosus GG on a twice-daily basis
Lactobacillus rhamnosus GG: 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis | 30 |
| Standard of Care Patients in the control arm will receive standard care | 40 |
| Total | 70 |
Baseline characteristics
| Characteristic | Probiotic | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 65 years | 59 years | 60 years |
| Race/Ethnicity, Customized Race Non-white race | 11 Participants | 16 Participants | 27 Participants |
| Race/Ethnicity, Customized Race White race | 19 Participants | 24 Participants | 43 Participants |
| Region of Enrollment United States | 30 participants | 40 participants | 70 participants |
| Sex: Female, Male Female | 18 Participants | 20 Participants | 38 Participants |
| Sex: Female, Male Male | 12 Participants | 20 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 40 |
| serious Total, serious adverse events | 0 / 30 | 0 / 40 |
Outcome results
Primary
Number of Participants With Combination of Gastrointestinal Tract Colonization With Multi-drug Resistant Gram-negative Bacteria, C. Difficile and VRE
Colonization of the gastrointestinal tract with C. difficile, vancomycin-resistant enterococci, multidrug-resistant Acinetobacter baumannii, and multidrug- resistant Pseudomonas. Colonization occurs when the subject acquires the above organism while in the study.
Time frame: Participants will be followed while Intubated, an expected average of 7 days. The outcome will be measured 3 days after enrollment and at the end of intubation, average time 7 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Probiotic | Number of Participants With Combination of Gastrointestinal Tract Colonization With Multi-drug Resistant Gram-negative Bacteria, C. Difficile and VRE | 8 Participants |
| Standard of Care | Number of Participants With Combination of Gastrointestinal Tract Colonization With Multi-drug Resistant Gram-negative Bacteria, C. Difficile and VRE | 8 Participants |