Prevention and Decolonization of Multidrug-resistant Bacteria With Probiotics

NCT ID: NCT03967301

Last Updated: 2019-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2019-12-31

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.

Conditions

Probiotics; Enterobacteriaceae Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Probiotic isolated intestinal bacteria (active)

Patients randomized to active arm, will consume 5ml every 12 hours per day of a suspension of probiotics (Bioflora ® Lactobacillus casei, Lactobacillus plantarum, Streptococcus faecalis y Bifidobacterium brevis) for 14 days.The content of each bottle is reconstituted up to 50 ml (10 doses) with drinking water The prescription of the intervention will be carried out and monitored through the electronic medical record. In the hospital setting, the probiotic is reconstituted by the nursing staff. If the patient is discharged before this period the patient and family will be instructed to perform the reconstitution at home.

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Intervention: defined as probiotic consumption

Placebo

Patients randomized to the placebo arm, will consume 5ml every 12 hours per day of a suspension of placebo for 14 days. The prescription of the intervention will be carried out and monitored through the electronic medical record.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo consumption. The placebo will be provided by the company that produces the probiotic.

Interventions

Probiotic

Intervention: defined as probiotic consumption

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo consumption. The placebo will be provided by the company that produces the probiotic.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Italiano de Buenos Aires

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Maria I Staneloni, MD

Role: CONTACT

maria.staneloni@hospitalitaliano.org.ar

1536670333.

Sol Burokas, MD

Role: CONTACT

maria.burokas@hiba.org.ar

541149590200 ext. 8165

Other Identifiers

3738

Identifier Type: -

Identifier Source: org_study_id