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Trial Outcomes & Findings for Probiotics to Promote Intestinal Health (NCT NCT02046512)

NCT ID: NCT02046512

Last Updated: 2022-04-04

Results Overview

Acquisition in the gastrointestinal tract of any new antibiotic resistant organism post-enrollment. Antibiotic resistant organisms include: C. difficile, vancomycin-resistant enterococci (VRE), multidrug-resistant Acinetobacter baumannii, multidrug-resistant Pseudomonas, ciprofloxacin-resistant Enterobacteriaceae, extended-spectrum betalactamase (ESBL) producing Enterobacteriaceae.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

89 participants

Primary outcome timeframe

Outcome will be measured approximately every 3 days after enrollment throughout hospitalization, and at the time of discharge (the median duration of hospitalization was 13.5 days).

Results posted on

2022-04-04

Participant Flow

Participant milestones

Participant milestones
Measure
Probiotic
Patients randomized to probiotic therapy will receive 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis Probiotic: 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis
Sugar Pill
Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis Placebo: Sugar pill
Overall Study
STARTED
45
44
Overall Study
COMPLETED
44
44
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Probiotics to Promote Intestinal Health

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Probiotic
n=44 Participants
Patients randomized to probiotic therapy will receive 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis Probiotic: 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis
Sugar Pill
n=44 Participants
Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis Placebo: Sugar pill
Total
n=88 Participants
Total of all reporting groups
Age, Customized
Age
58 years
n=5 Participants
60 years
n=7 Participants
59 years
n=5 Participants
Sex: Female, Male
Female
22 Participants
n=5 Participants
20 Participants
n=7 Participants
42 Participants
n=5 Participants
Sex: Female, Male
Male
22 Participants
n=5 Participants
24 Participants
n=7 Participants
46 Participants
n=5 Participants
Race/Ethnicity, Customized
White
24 Participants
n=5 Participants
25 Participants
n=7 Participants
49 Participants
n=5 Participants
Race/Ethnicity, Customized
Non-white
20 Participants
n=5 Participants
19 Participants
n=7 Participants
39 Participants
n=5 Participants
Region of Enrollment
United States
44 participants
n=5 Participants
44 participants
n=7 Participants
88 participants
n=5 Participants

PRIMARY outcome

Timeframe: Outcome will be measured approximately every 3 days after enrollment throughout hospitalization, and at the time of discharge (the median duration of hospitalization was 13.5 days).

Acquisition in the gastrointestinal tract of any new antibiotic resistant organism post-enrollment. Antibiotic resistant organisms include: C. difficile, vancomycin-resistant enterococci (VRE), multidrug-resistant Acinetobacter baumannii, multidrug-resistant Pseudomonas, ciprofloxacin-resistant Enterobacteriaceae, extended-spectrum betalactamase (ESBL) producing Enterobacteriaceae.

Outcome measures

Outcome measures
Measure
Probiotic
n=44 Participants
Patients randomized to probiotic therapy will receive 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis Probiotic: 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis
Sugar Pill
n=44 Participants
Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis Placebo: Sugar pill
Number of Participants With Acquisition of Any New Antibiotic-resistant Organism
9 Participants
12 Participants

Adverse Events

Probiotic

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sugar Pill

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

Kimberly Reske, Research Coordinator

Washington University in St. Louis School of Medicine

Phone: 3147474041

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place