A Phase 4 interventional study of Lactobacillus rhamnosus GG in Infectious Disease of Digestive Tract, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-17.
Sponsored by Washington University School of Medicine · Phase 4, Interventional, and Prevention
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.
4,452 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.
This study's enrollment of 103 is below the median of 122 across 2,718 interventional studies indexed under Communicable Diseases.
Browse Communicable Diseases studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients randomized to probiotic therapy will receive 1 capsule containing 1010 cells of Lactobacillus rhamnosus GG on a twice-daily basis
Dietary Supplement: Lactobacillus rhamnosus GG
Patients in the control arm will receive standard care
1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis
Also known as: Culturelle
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)
| Milestone | Probiotic | Standard of Care |
|---|---|---|
| Started | 50 | 53 |
| Completed | 30 | 40 |
| Not completed | 20 | 13 |
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.
| Participants | Probiotic | Standard of Care |
|---|---|---|
| Number of Participants With Combination of Gastrointestinal Tract Colonization With Multi-drug Resistant Gram-negative Bacteria, C. Difficile and VRE | 8 | 8 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Probiotic | — | 0/30 (0%) | 0/30 (0%) |
| Standard of Care | — | 0/40 (0%) | 0/40 (0%) |
| Age, Continuous(years) | Probiotic | Standard of Care | Total |
|---|---|---|---|
| Median | 65 (29 to 82) | 59 (32 to 82) | 60 (29 to 82) |
| Sex: Female, Male(Participants) | Probiotic | Standard of Care | Total |
|---|---|---|---|
| Female | 18 | 20 | 38 |
| Male | 12 | 20 | 32 |
| Race/Ethnicity, Customized(Participants) | Probiotic | Standard of Care | Total |
|---|---|---|---|
| Race — White race | 19 | 24 | 43 |
| Race — Non-white race | 11 | 16 | 27 |
| Region of Enrollment(participants) | Probiotic | Standard of Care | Total |
|---|---|---|---|
| United States | 30 | 40 | 70 |
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine