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出境医 / 临床实验 / Prevention and Decolonization of Multidrug-resistant Bacteria With Probiotics

Prevention and Decolonization of Multidrug-resistant Bacteria With Probiotics

Study Description
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.

Condition or disease Intervention/treatment Phase
Probiotics Enterobacteriaceae Infections Dietary Supplement: Probiotic Dietary Supplement: Placebo Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Official Title: Prevention and Decolonization of Carbapenemase-producing Enterobacteriaceae With Probiotics
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: 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.
 Dietary Supplement: Probiotic
Intervention: defined as probiotic consumption
Placebo Comparator: 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.
 Dietary Supplement: Placebo
Placebo consumption. The placebo will be provided by the company that produces the probiotic.
Outcome Measures
Primary Outcome Measures :
  1. presence of CRE in anal swab or stool culture in follow-up control: [ Time Frame: 12 weeks ]

    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



Secondary Outcome Measures :
  1. positive for clostridium difficile diarrhea [ Time Frame: 12 weeks ]

    If a patient develops diarrhea at some point during hospitalization, screening for Cd will be performed at the attending phisician´s discretion

    If the patient has diarrhea with a positive Cd toxin and is receiving probiotic he/she should leave the study and the data for CRE will be evaluated with the last available swab at the time of the exit event (positive for clostridium difficile diarrhea).



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Maria I Staneloni, MD 1536670333. maria.staneloni@hospitalitaliano.org.ar
Contact: Sol Burokas, MD 541149590200 ext 8165 maria.burokas@hiba.org.ar

Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Tracking Information
First Submitted Date  ICMJE February 3, 2019
First Posted Date  ICMJE May 30, 2019
Last Update Posted Date August 12, 2019
Estimated Study Start Date  ICMJE October 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2019) 		presence of CRE in anal swab or stool culture in follow-up control: [ Time Frame: 12 weeks ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2019) 		positive for clostridium difficile diarrhea [ Time Frame: 12 weeks ]
If a patient develops diarrhea at some point during hospitalization, screening for Cd will be performed at the attending phisician´s discretion If the patient has diarrhea with a positive Cd toxin and is receiving probiotic he/she should leave the study and the data for CRE will be evaluated with the last available swab at the time of the exit event (positive for clostridium difficile diarrhea).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention and Decolonization of Multidrug-resistant Bacteria With Probiotics
Official Title  ICMJE Prevention and Decolonization of Carbapenemase-producing Enterobacteriaceae With Probiotics
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Condition  ICMJE
  • Probiotics
  • Enterobacteriaceae Infections
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Dietary Supplement: Probiotic
  • Placebo Comparator: 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.
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 27, 2019) 		228
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Maria I Staneloni, MD 1536670333. maria.staneloni@hospitalitaliano.org.ar
Contact: Sol Burokas, MD 541149590200 ext 8165 maria.burokas@hiba.org.ar
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03967301
Other Study ID Numbers  ICMJE 3738
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital Italiano de Buenos Aires
Study Sponsor  ICMJE Hospital Italiano de Buenos Aires
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospital Italiano de Buenos Aires
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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