Fecal microbiota transplantation against intestinal colonization by multidrug resistant bacteria

ISRCTN	ISRCTN48328635
DOI	https://doi.org/10.1186/ISRCTN48328635
Secondary identifying numbers	FAME 2013_003

Submission date: 26/09/2017
Registration date: 11/10/2017
Last edited: 26/03/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Mr Pieter de Groot
Public

Meibergdreef 9
Amsterdam
1105AZ
Netherlands

Phone	+31 (0)636 123 516
Email	p.f.degroot@amc.nl

Study information

Study design	Uncontrolled single-center clinical trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Fecal microbiota transplantation against intestinal colonization by extended spectrum beta-lactamase producing Enterobacteriaceae
Study acronym	FAME
Study objectives	Fecal microbiota transplantation can reverse colonization by multidrug resistant intestinal bacteria.
Ethics approval(s)	The ethics committee of the Academic Medical Center (Amsterdam) (MEC-AMC), 06/03/2013
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2013
Completion date	11/04/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	15
Key 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)
Key exclusion criteria	Severe immunodeficiency
Date of first enrolment	30/05/2013
Date of final enrolment	11/04/2016

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Centre

Meibergdreef 9
Amsterdam
1105AZ
Netherlands

Sponsor information

Academic Medical Center
Hospital/treatment centre

Meibergdreef 9
Amsterdam
1105AZ
Netherlands

Website	www.amc.nl
"ROR"	https://ror.org/03t4gr691

Funders

Funder type

Government

Nierstichting
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Dutch Kidney Foundation
Location: Netherlands

ZonMw
Private sector organisation / Other non-profit organizations

Alternative name(s): Netherlands Organisation for Health Research and Development
Location: Netherlands

Nederlandse Organisatie voor Wetenschappelijk Onderzoek
Government organisation / National government

Alternative name(s): Netherlands Organisation for Scientific Research, Dutch National Scientific Foundation, Dutch National Science Foundation, Dutch Research Council (Nederlandse Organisatie voor Wetenschappelijk Onderzoek), NWO:Nederlandse Organisatie voor Wetenschappelijk Onderzoek, Nederlandse Organisatie voor Wetenschappelijk Onderzoek (NWO), Dutch Research Council, Dutch Research Council, Netherlands, NWO
Location: Netherlands

Results and Publications

Intention to publish date	31/12/2017
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	The trialists intend to publish as soon as the study is registered.
IPD sharing plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	22/03/2018		Yes	No

Editorial Notes

26/03/2018: Publication reference added.