Prevention and Decolonization of Multidrug-resistant Bacteria With Probiotics

NCT03967301 | Unknown DMC

• 1 other identifier: 3738
• Study Type: interventional
• Target: 228
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Probiotics; Enterobacteriaceae Infections

Keywords

Carbapenemase-producing Enterobacteriaceae; probiotics

Outcome Measures

Primary Outcomes (1)

• presence of CRE in anal swab or stool culture in follow-up control:

  CRE anal swab positive upon discharge, therapeutic adjustment or in-hospital death. ● Date of swab, therapeutic adjustment or in-hospital death. and within a month : ● Control CRE swab per month for KPC: Categorical binomial: Positive / Negative. Will be performed 30 days after enrollment and weekly for 8 weeks if positive. It will be considered negative when the patient as three consecutive negative swabs separated by a week. It will be persistently positive when during this period of follow-up at least one of the swabs is positive, total follow-up 12 weeks

  12 weeks

Secondary Outcomes (1)

• positive for clostridium difficile diarrhea

  12 weeks

Study Arms (2)

Probiotic isolated intestinal bacteria (active)

EXPERIMENTAL

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.

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Intervention: defined as probiotic consumption

Probiotic isolated intestinal bacteria (active)

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

MeSH Terms

Conditions

Enterobacteriaceae Infections

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Maria I Staneloni, MD

CONTACT

1536670333.; maria.staneloni@hospitalitaliano.org.ar

Sol Burokas, MD

CONTACT

541149590200; maria.burokas@hiba.org.ar

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2019
• First Posted: May 30, 2019
• Study Start: October 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 12, 2019

Record last verified: 2019-08