NCT03967301

Prevention and Decolonization of Multidrug-resistant Bacteria With Probiotics

Prevention and Decolonization of Carbapenemase-producing Enterobacteriaceae With Probiotics

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Hospital Italiano de Buenos Aires · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study explores the effect of probiotic administration to decrease colonization by Carbapenem resistant Enterobacteriaceae (CRE) in at-risk populations. Colonized patients will be randomized to receive probiotics or placebo for 14 days and reevaluated for colonization in follow up.

Detailed description

The use of antibiotics is known to have significant effects on the intestinal microbiota. Studies have linked this alteration with the risk of colonization and / or infection by Carbapenem resistant Enterobacteriaceae (CRE) and / or Clostridium difficile (Cd). The impact of these microorganisms has been demonstrated, with mortality rates in inpatients of around 30-50% for patients infected with CRE and 10% in Cd. It is necessary to implement mechanisms to contain dissemination and decrease colonization, in order to prevent infections caused by such agents. Probiotics are foods consisting of live microorganisms and could restore the balance of the microbiota and avoid colonization by multi-resistant germs. Systematic reviews have shown a protective effect of probiotics for Cd. Studies on the effect on CRE are scarce and have been related mostly to prevention of colonization. Among the probiotics obtained by bacterial fermentation technology and already available in pharmacopoeia we have Bioflora ®. The objective of this trial is to explore the effect of probiotic consumption to decrease the duration of the colonization by CRE by comparing the percentage of patients colonized with CRE after the administration of probiotics and in the untreated group. Methodology: Randomized clinical trial, single center. Known CRE colonized patients will be randomized to consume probiotics for 14 days or placebo. Then the colonization will be evaluated by means of anal swabs as indicated by the hospital standards with a follow up of 12 weeks from the initial intervention. If the patient is discharged, home follow-up will be scheduled to supervise the intake of the dietary supplement and the control swabs. The expected impact is to accelerate the process of decolonization of multi-resistant germs through the administration of probiotics leading to a shorter contact isolation time in and reducing the risk of complications in CRE colonized patients.

Conditions

• Probiotics
• Enterobacteriaceae Infections

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Intervention: defined as probiotic consumption
DIETARY_SUPPLEMENT	Placebo	Placebo consumption. The placebo will be provided by the company that produces the probiotic.

Timeline

• Start date: 2019-10-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2019-05-30
• Last updated: 2019-08-12