Probiotics to Promote Intestinal Health

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT02046512
Collaborator
Centers for Disease Control and Prevention (U.S. Fed)
89
1
2
59
1.5

Study Details

Study Description

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 broad spectrum antimicrobials.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Probiotic
  • Other: Placebo
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
89 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Randomized Controlled Trial of Lactobacillus Rhamnosus GG to Promote Intestinal Health
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Probiotic

Patients randomized to probiotic therapy will receive 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis

Dietary Supplement: Probiotic
1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis
Other Names:
  • Culturelle
  • Placebo Comparator: Sugar Pill

    Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis

    Other: Placebo
    Sugar pill

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Acquisition of Any New Antibiotic-resistant Organism [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adults ≥ 18 years old

    • Admission to the non-ICU medical and surgical wards

    • On broad spectrum antimicrobials with an anticipated length of stay of >48 hours

    Exclusion Criteria:
    • Pregnancy

    • Non English speaking

    • Expected to die within 7 days

    • Unable or unwilling to consent

    • HIV infection with a CD4 count <200

    • Neutropenia with an absolute neutrophil count less than 500 cells/ml (or expected to drop to less than 500)

    • Clinically significant diarrhea or history of C. difficile infection in the last 3 months

    • History of VRE colonization and/or infection in the last year

    • Transplant recipients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington University School of Medicine Saint Louis Missouri United States 63110

    Sponsors and Collaborators

    • Washington University School of Medicine
    • Centers for Disease Control and Prevention

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT02046512
    Other Study ID Numbers:
    • 201310102
    • CK000162-aim3
    First Posted:
    Jan 27, 2014
    Last Update Posted:
    Apr 4, 2022
    Last Verified:
    Mar 1, 2022
    Keywords provided by Washington University School of Medicine
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Probiotic Sugar Pill
    Arm/Group Description 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 Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis Placebo: Sugar pill
    Period Title: Overall Study
    STARTED 45 44
    COMPLETED 44 44
    NOT COMPLETED 1 0

    Baseline Characteristics

    Arm/Group Title Probiotic Sugar Pill Total
    Arm/Group Description 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 Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis Placebo: Sugar pill Total of all reporting groups
    Overall Participants 44 44 88
    Age, Customized (years) [Median (Full Range) ]
    Age
    58
    60
    59
    Sex: Female, Male (Count of Participants)
    Female
    22
    50%
    20
    45.5%
    42
    47.7%
    Male
    22
    50%
    24
    54.5%
    46
    52.3%
    Race/Ethnicity, Customized (Count of Participants)
    White
    24
    54.5%
    25
    56.8%
    49
    55.7%
    Non-white
    20
    45.5%
    19
    43.2%
    39
    44.3%
    Region of Enrollment (participants) [Number]
    United States
    44
    100%
    44
    100%
    88
    100%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Acquisition of Any New Antibiotic-resistant Organism
    Description 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.
    Time Frame 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).

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Probiotic Sugar Pill
    Arm/Group Description 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 Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis Placebo: Sugar pill
    Measure Participants 44 44
    Count of Participants [Participants]
    9
    20.5%
    12
    27.3%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Probiotic Sugar Pill
    Arm/Group Description 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 Patients randomized to placebo therapy will receive an identical appearing placebo capsule on a twice-daily basis Placebo: Sugar pill
    All Cause Mortality
    Probiotic Sugar Pill
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Probiotic Sugar Pill
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/44 (0%) 0/44 (0%)
    Other (Not Including Serious) Adverse Events
    Probiotic Sugar Pill
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/44 (0%) 0/44 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Kimberly Reske, Research Coordinator
    Organization Washington University in St. Louis School of Medicine
    Phone 3147474041
    Email kreske@wustl.edu
    Responsible Party:
    Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT02046512
    Other Study ID Numbers:
    • 201310102
    • CK000162-aim3
    First Posted:
    Jan 27, 2014
    Last Update Posted:
    Apr 4, 2022
    Last Verified:
    Mar 1, 2022