Condition category
Infections and Infestations
Date applied
26/09/2017
Date assigned
11/10/2017
Last edited
26/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

www.amc.nl

Funders

Funder type

Government

Funder name

Nierstichting

Alternative name(s)

Dutch Kidney Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

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

Federal/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

Publication citations

Additional files

Editorial Notes

26/03/2018: Publication reference added.