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Probiotics to Promote Intestinal Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02046512
Recruitment Status : Completed
First Posted : January 27, 2014
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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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
Communicable Diseases Infection Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Dietary Supplement: Probiotic Other: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 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 : January 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 2018

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Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. Change in the composition of the intestinal flora with a focus on multidrug-resistant organisms (MDRO) in the intention to treat population (ITT). [ Time Frame: Outcome will be measured every 3 days after enrollment, at the time of discharge, and at 60 days post-discharge ]
    Colonization of the gastrointestinal tract with C. difficile, vancomycin-resistant enterococci (VRE), multidrug-resistant Acinetobacter baumannii, and multidrug-resistant Pseudomonas. Colonization occurs when the subject acquires the above organism while in the study.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046512


Locations
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United States, Missouri
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
More Information
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Publications:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02046512    
Other Study ID Numbers: 201310102
CK000162-aim3 ( Other Grant/Funding Number: Centers for Disease Control and Prevention )
First Posted: January 27, 2014    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Keywords provided by Washington University School of Medicine:
Probiotics
Additional relevant MeSH terms:
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Communicable Diseases
Infections
Disease Attributes
Pathologic Processes