Probiotics to Promote Intestinal Health

The Washington University

Status and phase: Completed; Phase 4

Conditions: Infection; Pharmacologic Actions; Anti-Infective Agents; Therapeutic Uses; Communicable Diseases

Treatments: Other: Placebo; Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02046512

CK000162-aim3 (Other Grant/Funding Number)

201310102

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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89 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotic

Sugar Pill

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo