The Use of Probiotics to Evaluate Colonization With Antimicrobial Resistant Bacteria

The Washington University

Status and phase: Completed; Phase 4

Conditions: Infectious Disease of Digestive Tract

Treatments: Dietary Supplement: Lactobacillus rhamnosus GG

Study type: Interventional

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

Identifiers

NCT01551186

201106182

1U54CK000162 (U.S. NIH Grant/Contract)

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 a ventilator.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults ≥ 18 years old
• Admission to the Medical ICU
• Expected to be on Mechanical Ventilation through an endotracheal tube for >48 hours

Exclusion criteria

• Pregnancy
• Immunosuppression
• Prosthetic valve or vascular graft
• Cardiac trauma
• Pancreatitis
• History of rheumatic fever
• Endocarditis or congenital cardiac abnormality
• Gastroesophageal or intestinal injury or foregut surgery during the current admission
• Oropharyngeal mucosal injury
• Placement of a tracheostomy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

103 participants in 2 patient groups

Probiotic

Experimental group

Description:

Patients randomized to probiotic therapy will receive 1 capsule containing 1010 cells of Lactobacillus rhamnosus GG on a twice-daily basis

Treatment:

Dietary Supplement: Lactobacillus rhamnosus GG

Standard of Care

No Intervention group

Description:

Patients in the control arm will receive standard care