Plain English Summary
Background and study aims
Recurrent infections with antibiotic-resistant bacteria are a major health problem as they are associated with increased hospitalization, medication costs and mortality (death). The aim of this study is to treat patients carrying antibiotic-resistant bacteria with a fecal transplant from a donor.
Who can participate?
Patients carrying enterobacteriaceae with extended-spectrum beta lactamase (ESBL-EB)
What does the study involve?
Rectal swabs are taken at the start of the study and 1 week before the fecal transplantation. The fecal solution is administered through a tube into the small intestine. The treatment takes about 30 minutes with an observation period of 1 to 3 hours. Rectal swab samples are collected at 1, 2 and 4 weeks follow-up. Fecal samples are taken for bacterial analysis before the fecal infusion and at 4 weeks follow-up.
What are the possible benefits and risks of participating?
Participants may benefit from being free of antibiotic-resistant bacteria, so that when infection occurs this should be easier to cure with antibiotics. The risks are discomfort, nausea, and a small chance of infection despite proper donor testing.
Where is the study run from?
Academic Medical Centre (Netherlands)
When is the study starting and how long is it expected to run for?
January 2013 to April 2016
Who is funding the study?
1. Dutch Kidney Foundation
2. Netherlands Organisation for Health Research and Development
3. Netherlands Organisation for Scientific Research
Who is the main contact?
Pieter de Groot
p.f.degroot@amc.nl
Trial website
Contact information
Type
Public
Primary contact
Mr Pieter de Groot
ORCID ID
Contact details
Meibergdreef 9
Amsterdam
1105AZ
Netherlands
+31 (0)636 123 516
p.f.degroot@amc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
FAME 2013_003
Study information
Scientific title
Fecal microbiota transplantation against intestinal colonization by extended spectrum beta-lactamase producing Enterobacteriaceae
Acronym
FAME
Study hypothesis
Fecal microbiota transplantation can reverse colonization by multidrug resistant intestinal bacteria.
Ethics approval
The ethics committee of the Academic Medical Center (Amsterdam) (MEC-AMC), 06/03/2013
Study design
Uncontrolled single-center clinical trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Extended spectrum beta-lactamase producing Enterobacteriaceae carriership
Intervention
Rectal swabs were taken at the moment of inclusion and <1 week before the fecal transplantation. Fecal solution was administered by duodenal tube which was placed by CORTRAK-technology, treatment duration (fecal infusion) lasted about 30 minutes with an observation period of 1 to 3 hours. Rectal swab follow-up samples were collected at 1,2 and 4 weeks follow-up. Fecal samples for microbiota analysis were taken before fecal infusion and at 4 weeks follow-up.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Negative cultures for ESBL, assessed with MALDI-TOF MS using the Bruker Biotyper (Bruker Daltonics, Germany) and antimicrobial susceptibility testing performed using the VITEK2 system (bioMérieux). Rectal swabs taken at 0, 1, 2, 4 weeks
Secondary outcome measures
Fecal microbiota analyzed by human intestinal tract (HIT-)chip from samples taken at 0 and 4 weeks
Overall trial start date
01/01/2013
Overall trial end date
11/04/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients carrying enterobacteriaceae with extended-spectrum beta lactamase (ESBL-EB) on two consecutive cultures, one of which at most 1 week before fecal microbiota transplantation (FMT)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
15
Participant exclusion criteria
Severe immunodeficiency
Recruitment start date
30/05/2013
Recruitment end date
11/04/2016
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre
Meibergdreef 9
Amsterdam
1105AZ
Netherlands
Sponsor information
Organisation
Academic Medical Center
Sponsor details
Meibergdreef 9
Amsterdam
1105AZ
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Nierstichting
Alternative name(s)
Dutch Kidney Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Netherlands
Funder name
ZonMw
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
Netherlands
Funder name
Nederlandse Organisatie voor Wetenschappelijk Onderzoek
Alternative name(s)
Netherlands Organisation for Scientific Research, Dutch National Scientific Foundation, Dutch National Science Foundation, NWO
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Netherlands
Results and Publications
Publication and dissemination plan
The trialists intend to publish as soon as the study is registered.
IPD sharing statement
SPSS and Excel databases and R-code will be available upon request to p.f.degroot@amc.nl or m.nieuwdorp@amc.nl. Data will be shared by e-mail. Data is fully anonymized and meets the criteria of the ethics review board.
Intention to publish date
31/12/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29566738