Clinical trial NCT03967301: Prevention and Decolonization of Multidrug-resistant Bacteria With Probiotics
Official title: Prevention and Decolonization of Carbapenemase-producing Enterobacteriaceae With Probiotics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Probiotics
Enterobacteriaceae Infections
Keywords: Carbapenemase-producing Enterobacteriaceae
probiotics
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* CRE- colonized patients
* adult patients in hospital (over 18 years old)
* Part of the HIBA health care plan
* CRE positive rectal swab or stool in the last 14 days

Exclusion criteria:

* Enteral route enabled (oral, nasogastric tube, gastrostomy or jejunostomy)
* Refusal to participate in the study
* Not available for weekly checks, minimum up to 12 weeks from enrollment
* Clostridium difficile active infection concomitant with CRE swab in a 14-day period days
* Neutropenia G3 or greater (less than 1000 neutrophils at the time of enrollment).
* Severe immunosuppressed at the time of recruitment according to the CDC definition (patients transplanted, HIV with CD4 \<200, congenital immunodeficiencies, leukemias, lymphomas, cancer disseminated, current chemotherapy or radiotherapy, treatment with corticoids high dose:prednisone 20 mg / d\> 2 weeks or immunosuppressive drugs).
* Patient with valvular prostheses
* Imminent death
* Fistula or dehiscence of the gastrointestinal tract
* Acute pancreatitis
* Patient of critical units in ileus and / or with high requirement of vasopressors (noradrenaline equal to or greater than 0.5 gammas) at the time of recruitment

Primary outcomes:
measure: presence of CRE in anal swab or stool culture in follow-up control:
timeFrame: 12 weeks
Secondary outcomes:
measure: positive for clostridium difficile diarrhea
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References: