ProbioticsNCT03967301
Prevention and Decolonization of Multidrug-resistant Bacteria With Probiotics
A study testing Probiotic in people with Probiotics and Enterobacteriaceae Infections, run by Hospital Italiano de Buenos Aires.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Probiotics, Enterobacteriaceae Infections
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- Probiotic, Placebo
- Keywords
- Carbapenemase-producing Enterobacteriaceae, probiotics
- Medical subject headings
- Enterobacteriaceae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Intervention: defined as probiotic consumption
PlaceboDietary supplement
Placebo consumption. The placebo will be provided by the company that produces the probiotic.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (1)
positive for clostridium difficile diarrhea
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study startOct 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProbioticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967301
- Sponsor's protocol ID
- 3738
- Status last verified
- Aug 2019
- First submitted
- 3 Feb 2019
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Decolonization of Carbapenemase-producing Enterobacteriaceae With Probiotics
- ClinicalTrials.gov ID
- NCT03967301
- Acronym / sponsor ID
- 3738
- Conditions
- Probiotics, Enterobacteriaceae Infections
- Keywords
- Carbapenemase-producing Enterobacteriaceae, probiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic isolated intestinal bacteria (active) | Experimental | Dietary Supplement: ProbioticPatients 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticIntervention: defined as probiotic consumption | Dietary supplement | Probiotic isolated intestinal bacteria (active) |
| PlaceboPlacebo consumption. The placebo will be provided by the company that produces the probiotic. | Dietary supplement | Placebo |
Primary outcome
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
1 secondary outcome
positive for clostridium difficile diarrhea
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Probiotics and Enterobacteriaceae Infections, run by Hospital Italiano de Buenos Aires.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria I Staneloni, MD (1536670333., maria.staneloni@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of CRE in anal swab or stool culture in follow-up control: (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.