- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03391674
Fecal Microbiota Transplantation for Eradication of Carbapenem-resistant Enterobacteriaceae Colonization
January 21, 2020 updated by: Rambam Health Care Campus
Fecal Microbiota Transplantation for Eradication of Carbapenem-resistant Enterobacteriaceae Colonization: A Randomized Control Trial
Antibiotic resistance has emerged world wide and is of major concern.
Multidrug resistant (MDR) bacteria is widely spread and is now a major factor in morbidity and mortality in health-care settings.
Among MDRs, carbapenem resistant Enterobacteriaceae (CRE) are of special concern, receiving the highest classification of "urgent threat level" in the US President Report.
Consistent mortality rates of 40-50% are observed among inpatients with infections caused by CRE in hospitals worldwide, related mainly to unavailable, delayed or ineffective antibiotic treatment options.
The extremely high mortality rates of patients with CRE infections have driven efforts to prevent the acquisition and spread of these bacteria in hospitals.
These include screening for carriage, contact isolation of carriers, cohorting, dedicated healthcare staff and other infection control measures.
These strategies have been proven as effective but are cumbersome and expensive.
In most locations these strategies failed to completely eradicate CRE endemicity.
CRE decolonization (eradication of colonization) might offer a double benefit - reducing the risk for the individual carrier to develop an infection due to the resistant strain (by that, potentially lowering the mortality risk) and preventing the bacteria from spreading to other patients, exposing them to the same hazard.
Fecal microbiota transplantation (FMT), in which fecal material enriched with commensal microorganisms is transferred from a healthy donor, have proven efficacy in the treatment of recurrent Clostridium difficile infection (CDI) in multiple trails.
Major adverse events that has been reported so far are mostly related to the route of administration (aspiration during nasogastric tube administration/colonoscopy).
Other adverse events include mostly GI related symptoms (diarrhea, nausea, belching) and are self limited and resolve in few hours.
FMT seems to be safe and effective both in immunocompetent and immunocompromised patients.
The high efficacy of FMT in the treatment of a multi-drug resistant pathogen such as Clostridium difficile, suggest that it might be an efficient tool for other MDR pathogens (e.g.
CRE).
This study aim to assess the effects of FMT on colonization and clinical infections with CRE.
The potential of FMT to restore the gut microbiome and compete with residual resistant strains offer a novel way to fight the current MDR epidemic.
FMT will be applied in a randomized open label fashion to CRE carriers in a single center in Israel and will be given by capsules for 2 consecutive days followed by rectal sampling at predefined timepoint in the following 6 months.
Study Overview
Status
Withdrawn
Intervention / Treatment
Detailed Description
Antibiotic resistance has emerged world wide and is of major concern.
Multidrug resistant (MDR) bacteria is widely spread and is now a major factor in morbidity and mortality in health-care settings.
Among MDRs, carbapenem resistant Enterobacteriaceae (CRE) are of special concern, receiving the highest classification of "urgent threat level" in the US President Report.
Consistent mortality rates of 40-50% are observed among inpatients with infections caused by CRE in hospitals worldwide, related mainly to unavailable, delayed or ineffective antibiotic treatment options.
The extremely high mortality rates of patients with CRE infections have driven efforts to prevent the acquisition and spread of these bacteria in hospitals.
These include screening for carriage, contact isolation of carriers, cohorting, dedicated healthcare staff and other infection control measures.
These strategies have been proven as effective but are cumbersome and expensive.
In most locations these strategies failed to completely eradicate CRE endemicity.
CRE decolonization (eradication of colonization) might offer a double benefit - reducing the risk for the individual carrier to develop an infection due to the resistant strain (by that, potentially lowering the mortality risk) and preventing the bacteria from spreading to other patients, exposing them to the same hazard.
Fecal microbiota transplantation (FMT), in which fecal material enriched with commensal microorganisms is transferred from a healthy donor, have proven efficacy in the treatment of recurrent Clostridium difficile infection (CDI) in multiple trails.
Major adverse events that has been reported so far are mostly related to the route of administration (aspiration during nasogastric tube administration/colonoscopy).
Other adverse events include mostly GI related symptoms (diarrhea, nausea, belching) and are self limited and resolve in few hours.
FMT seems to be safe and effective both in immunocompetent and immunocompromised patients.
The high efficacy of FMT in the treatment of a multi-drug resistant pathogen such as Clostridium difficile, suggest that it might be an efficient tool for other MDR pathogens (e.g.
CRE).
We aim to assess the effects of FMT on colonization and clinical infections with CRE.
The potential of FMT to restore the gut microbiome and compete with residual resistant strains offer a novel way to fight the current MDR epidemic.
FMT will be applied in a randomized open label fashion to CRE carriers in a single center in Israel and will be given by capsules for 2 consecutive days followed by rectal sampling at predefined timepoint in the following 6 months.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Haifa, Israel
- Rambam Health Care Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult inpatients ≥18 years positive for CRE of any strain and resistance mechanism in rectal surveillance stool samples, with or without CRE clinical samples. Positive rectal swab within one week before randomization will be mandatory.
Exclusion Criteria:
- Pregnant women
- Patients with severe neutropenia (<100/μl)
- Major abdominal surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fecal Microbiota Transplantation
Patients able to swallow will be given capsulized FMT using 15 capsules a day for two consecutive days.
Patients will be treated concomitantly with omeprazole 20mg once in the evening before FMT and daily for the next 2 days.
|
Fecal Microbiota Transplantation through oral capsules after omeprazole pre-treatment
|
No Intervention: Observational
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CRE Decolonization defined as 3 consecutive negative rectal samples for CRE
Time Frame: 3 months after intervention
|
3 consecutive negative rectal samples for CRE, last of which include a negative Polymerase chain reaction (PCR) test
|
3 months after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2019
Primary Completion (Actual)
January 1, 2020
Study Completion (Actual)
January 1, 2020
Study Registration Dates
First Submitted
December 4, 2017
First Submitted That Met QC Criteria
January 4, 2018
First Posted (Actual)
January 5, 2018
Study Record Updates
Last Update Posted (Actual)
January 22, 2020
Last Update Submitted That Met QC Criteria
January 21, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0338-19-RMB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Microbial Colonization
-
Karolinska InstitutetCompletedMicrobial Colonization and Colorectal Disease
-
NHS FifeUniversity of TurkuUnknownDental Caries | Oral Microbial ColonizationUnited Kingdom
-
University Magna GraeciaRecruiting
-
BLIS Technologies LimitedRecruiting
-
Min-Tze LIONGInternational Islamic University MalaysiaRecruiting
-
VU University of AmsterdamWageningen University and Research; Maag Lever Darm Stichting; Cidrani; WholeFiber and other collaboratorsActive, not recruiting
-
BLIS Technologies LimitedActive, not recruiting
-
Becton, Dickinson and CompanyCompleted
-
Washington University School of MedicineCompletedMicrobial ColonizationUnited States
-
Cairo UniversityUnknown
Clinical Trials on Fecal Microbiota Transplantation
-
Madhusudan (Madhu) Grover, MBBSRecruiting
-
Medical University of GrazBristol-Myers SquibbTerminatedMalignant Melanoma Stage III | Malignant Melanoma Stage IV | Fecal Microbiota TransplantationAustria
-
Children's Mercy Hospital Kansas CityUniversity of Pittsburgh; Stanford UniversityCompletedUlcerative Colitis (UC) | Inflammatory Bowel Diseases (IBD) | Crohn's Disease (CD)United States
-
The Second Hospital of Nanjing Medical UniversitySIR RUN RUN hospital of Nanjing Medical UniversityNot yet recruitingAttention-deficit/Hyperactivity DisorderChina
-
The Second Hospital of Nanjing Medical UniversityNot yet recruiting
-
The Second Hospital of Nanjing Medical UniversityRecruitingCancer | Intestinal ComplicationsChina
-
The First Affiliated Hospital of Nanchang UniversityCompletedAcute Pancreatitis | Intestinal Bacteria Flora Disturbance | Fecal Microbiota Transplantation | Intestinal DysfunctionChina
-
The Second Hospital of Nanjing Medical UniversityWithdrawnCOVID-19 Complicated With Refractory Intestinal InfectionsChina
-
The Second Hospital of Nanjing Medical UniversitySIR RUN RUN hospital of Nanjing Medical UniversityRecruiting
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingAllogeneic Hematopoietic Stem CellUnited States