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Fecal microbiota transplantation for eradication of Vancomycin-Resistant Enterococci


- candidate number28411
- NTR NumberNTR6936
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jan-2018
- Secondary IDs17-926 METC Utrecht
- Public TitleFecal microbiota transplantation for eradication of Vancomycin-Resistant Enterococci
- Scientific TitleFecal microbiota transplantation for eradication of Vancomycin-Resistant Enterococci: a pilot study.
- ACRONYMFAVOR
- hypothesisFecal Microbiota transplantation, applied through a nasoduodenal tube will eliminate intestinal carriage of VRE after a six month follow up period.
- Healt Condition(s) or Problem(s) studiedAntimicrobial resistance, Vancomycin-resistant Enterococci
- Inclusion criteria- Adult patients (≥18 years old at date of inclusion)
- Ability to provide informed consent
- Documented intestinal carriage of VRE by stool culture at baseline (visit 0)
- Exclusion criteria- Difficult / impossible follow-up
- Pregnancy or planned pregnancy or breastfeeding
- Allergy or other contraindication to colofort
- Severe food allergy (anaphylaxis, urticaria) - Recurrent aspirations / chronic dysphagia or
anatomic contraindication to the placement of a nasoduodenal tube
- Congestive heart failure class III-IV
- Estimated life expectancy < 6 months
- Current hospitalization in an Intensive Care Unit
- Treatment with any systemic antibiotic on the day of inclusion
- Severe immunodeficiency
- Systemic chemotherapy ≤ 30 days from baseline or planned chemotherapy within the next 12 months
- Human Immunodeficiency Virus (HIV) with CD4 count < 250/mcl
- Neutropenia with an absolute neutrophil count <1000/µL
- Hematopoietic stem cell transplant recipients
- Solid organ transplant recipients
- Inflammatory Bowel Disease (Crohn’s disease, Colitis Ulcerosa)
- Estimated glomerular filtration rate (CKD-EPI) < 15 ml/min/1.73m2
- Unavailability of compatible FMT preparation (with regard to donor / recipient CMV, EBV and Toxoplasma serology)
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-feb-2018
- planned closingdate1-jan-2019
- Target number of participants10
- InterventionsBowel lavage, followed by infusion of 198 mL of a standardized stool suspension through a duodenal tube (FMT)
- Primary outcomeThe primary endpoint will be intestinal carriage of VRE (absence/presence by stool culture of VRE) 6 months / 170 - 185 days after intervention.
- Secondary outcomeThe secondary endpoint will be intestinal carriage of VRE (absence/presence by stool culture of VRE) 12 months / 355 - 375 days after intervention.
- Timepoints1. Screening visit (SV): study is proposed at outpatient clinic, one fecontainer will be handed out.
2. Visit 0 (V0): Signing informed consent at outpatient clinic and collection of baseline data (history and physical examination, collecting feces for microbiological tests, blood exam), providing more detailed information about procedures. Scheduling appointments for visit 1 and FMT.
3. Visit 1 (V1): Instructions at outpatient clinic. Colofort for bowel lavage will be provided to the patient with instructions for use. Fecontainers will be provided. The research physician will check, again, all inclusion and exclusion criteria and patient willingness to participate.
4. The day before Visit 2: Bowel lavage at home.
5. Visit 2 (V2): FMT at outpatient clinic
6. Visit 3 (V3): Telephone appointment at T=1 week, which will consist of history taking and making sure the participant has collected a feces sample which will be sent through courier service to the microbiological laboratory.
7. Visit 4 (V4): Telephone appointment at T=1 month, which will consist of history taking and making sure the participant has collected a feces sample which will be sent through courier service to the microbiological laboratory.
8. Visit 5 (V5): Appointment at outpatient clinic at T=6 month, which will consist of history taking, collecting a feces sample and a final blood exam.
9. Visit 6 (V6) Telephone appointment at T=12 months, which will consist of history taking and making sure the participant has collected a feces sample which will be sent through courier service to the microbiological laboratory.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc. E. Rademaker
- CONTACT for SCIENTIFIC QUERIESProf. Dr. M.J.M. Bonten
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Vedanta Biosciences, Inc.
- Publications
- Brief summaryRationale: Antimicrobial resistance is a growing threat for global health as treatment options for drug-resistant bacterial infections are limited. Uncertainty persists about possibilities to eradicate intestinal carriage of drug-resistant bacteria. Patients who are intestinal carriers of Vancomycin-Resistant Enterococcus may attain subsequent infections with few treatment options. Elimination of such carriage is therefore of clinical interest. Fecal Microbiota Transplantation (FMT) is increasingly used for the treatment of recurrent Clostridium difficile infections in humans and evidence is growing that FMT could also be an approach to restore a healthy intestinal microbiota to clear VRE colonization.
Objective: To assess the impact of bowel lavage followed by FMT on detectable intestinal carriage (by stool culture) of VRE in a 12 month follow-up period.
Study design: Prospective, open-label, phase II, observational pilot study.
Study population: Adult patients (≥18 years old) who are able to provide informed consent, with documented intestinal carriage of VRE at baseline (visit 0).
Intervention (if applicable): Bowel lavage, followed by infusion of 198 mL of a standardized stool suspension through a duodenal tube (FMT)
Main study parameters/endpoints: The primary endpoint will be intestinal carriage of VRE (absence/presence by stool culture of VRE) 6 months / 170 - 185 days after intervention. The secondary endpoint will be intestinal carriage of VRE (absence/presence by stool culture of VRE) 12 months / 355 - 375 days after intervention.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The burden for participants consists of 6 hospital visits, the bowel lavage, the FMT procedure, the collection of feces during the follow-up period and at least 3 telephone appointments. If the patient is not able to come to the hospital, 5 out of 6 hospital visits can be exchanged for a home visit by the investigator, with exception of Visit 2 (FMT).

Hospital visits:
1. Screening visit (SV): study is proposed at outpatient clinic, one fecontainer will be handed out.
2. Visit 0 (V0): Signing informed consent at outpatient clinic and collection of baseline data (history and physical examination, collecting feces for microbiological tests, blood exam), providing more detailed information about procedures. Scheduling appointments for visit 1 and FMT.
3. Visit 1 (V1): Instructions at outpatient clinic. Colofort for bowel lavage will be provided to the patient with instructions for use. Fecontainers will be provided. The research physician will check, again, all inclusion and exclusion criteria and patient willingness to participate.
4. The day before Visit 2: Bowel lavage at home.
5. Visit 2 (V2): FMT at outpatient clinic
6. Visit 3 (V3): Telephone appointment at T=1 week, which will consist of history taking and making sure the participant has collected a feces sample which will be sent through courier service to the microbiological laboratory.
7. Visit 4 (V4): Telephone appointment at T=1 month, which will consist of history taking and making sure the participant has collected a feces sample which will be sent through courier service to the microbiological laboratory.
8. Visit 5 (V5): Appointment at outpatient clinic at T=6 month, which will consist of history taking, collecting a feces sample and a final blood exam.
9. Visit 6 (V6) Telephone appointment at T=12 months, which will consist of history taking and making sure the participant has collected a feces sample which will be sent through courier service to the microbiological laboratory.

The study will examine whether it is possible to eradicate intestinal carriage with VRE by bowel lavage followed by administration of “healthy” stool flora obtained from the NDFB, through a tube inserted in the nose and ending in the duodenum. The benefit of participation in this trial is eradication of VRE-carriage and thereby reducing the risk of future infections caused by this bacterium. This benefit outweighs the involved risks.
- Main changes (audit trail)
- RECORD8-jan-2018 - 12-jan-2018


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