Fecal microbiota transplantation against intestinal colonization by multidrug resistant bacteria
| ISRCTN | ISRCTN48328635 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48328635 |
| Protocol serial number | FAME 2013_003 |
| Sponsor | Academic Medical Center |
| Funders | Nierstichting, ZonMw, Nederlandse Organisatie voor Wetenschappelijk Onderzoek |
- 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
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
Public
Meibergdreef 9
Amsterdam
1105AZ
Netherlands
| Phone | +31 (0)636 123 516 |
|---|---|
| p.f.degroot@amc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Uncontrolled single-center clinical trial |
| Secondary study design | Non randomised study |
| Study type | Participant 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(s) |
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 |
| Key secondary outcome measure(s) |
Fecal microbiota analyzed by human intestinal tract (HIT-)chip from samples taken at 0 and 4 weeks |
| Completion date | 11/04/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
Amsterdam
1105AZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
26/03/2018: Publication reference added.
