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OpenTrials
Completed

NCT Number: NCT02046512

Probiotics to Promote Intestinal Health

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.

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Key information

Conditions

Communicable Diseases Anti-Infective Agents Disease Attributes Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pharmacologic Actions Therapeutic Uses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Dietary Supplement

1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis

Other names: Culturelle

Placebo

Other

Sugar pill

Primary outcomes

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

    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).

    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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

Randomized Controlled Trial of Lactobacillus Rhamnosus GG to Promote Intestinal Health

Important dates

Study start
2014
Primary completion
2015
Study completion
2018
First posted
Jan 27, 2014
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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