Trial Outcomes & Findings for The Use of Probiotics to Evaluate Colonization With Antimicrobial Resistant Bacteria (NCT NCT01551186)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

103 participants

Primary outcome timeframe

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)

Results posted on

2018-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	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	Standard of Care Patients in the control arm will receive standard care
Overall Study STARTED	50	53
Overall Study COMPLETED	30	40
Overall Study NOT COMPLETED	20	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Use of Probiotics to Evaluate Colonization With Antimicrobial Resistant Bacteria

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Probiotic n=30 Participants 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	Standard of Care n=40 Participants Patients in the control arm will receive standard care	Total n=70 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	59 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	20 Participants n=7 Participants	32 Participants n=5 Participants
Race/Ethnicity, Customized Race · White race	19 Participants n=5 Participants	24 Participants n=7 Participants	43 Participants n=5 Participants
Race/Ethnicity, Customized Race · Non-white race	11 Participants n=5 Participants	16 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	40 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Probiotic n=30 Participants 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	Standard of Care n=40 Participants Patients in the control arm will receive standard care
Number of Participants With Combination of Gastrointestinal Tract Colonization With Multi-drug Resistant Gram-negative Bacteria, C. Difficile and VRE	8 Participants	8 Participants

Adverse Events

Probiotic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Erik Dubberke, MD, MSPH

Washington University School of Medicine, St. Louis, Missouri

Phone: 314-454-8354

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place