Probiotics Clinical Trial
Official title:
Prevention and Decolonization of Carbapenemase-producing Enterobacteriaceae With Probiotics
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.
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.
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