Microbial ColonizationPhase 4FEDEXNCT03029078
FEcal Transplant, a Hope to Eradicate Colonization of Patient Harboring eXtreme Drug Resistant Bacteria?
A Phase 4 study testing fecal microbiota transplant in people with Microbial Colonization and Bacterial Peritonitis, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
Our trial try to eradicate digestive tract colonization of patient harboring Extreme Drug Resistant (XDR) bacteria by performing a fecal transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microbial Colonization, Bacterial Peritonitis, Faeces Smearing
- What is being tested?
- fecal microbiota transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2014to 1 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient harboring a VRE or CRE bacteria
- Colonization confirmed by our microbiology department, including at least 3 positives swabs in the last month
Who cannot join
- Pregnant woman or breastfeeding
- immunosuppression including AIDS, corticosteroids over 60mg/day
- ongoing antibiotic treatment at the day of inclusion
- impossibility to obtain a signed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Our trial try to eradicate digestive tract colonization of patient harboring Extreme Drug Resistant (XDR) bacteria by performing a fecal transplantation.
Read the detailed description
Main objective:
Evaluate the eradication of the colonization of patient harboring XDR bacteria after a fecal transplantation from a healthy donor.
Secondary objectives:
English Evaluate the side effects of this procedure and tolerability. Evaluate the efficacy of the transplant if the patient is harboring glycopeptid resistant enteroccus (GRE) or carbapenem resistant enterobacteriae (CRE)
- Being tested
- fecal microbiota transplant
- Keywords
- XDR, fecal microbiota transplant, eradicate, colonization, CRE, GRE, bacteria
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal microbiota transplantDrug
Also called FEDEX
We will perform a fecal microbiota transplant for patients harboring XDR bacteria in their digestive tract
| Study group | Role | What they receive |
|---|---|---|
| Fecal transplantation | Experimental | Patient will be transplanted with a healthy donor microbiota, free from XDR bacteria, in order to evaluate the impact on the digestive tract colonization Whole process of feces screening and reconstitution was under the responsibility of the pharmacists in charge of the study.
Patient will benefit of a naso-duodenal tube in order to perform a bowel lavage prio to the fecal microbiota transplant.
Patient will be monitored for 24h to rule out potential adverse events. Receives: Drug: fecal microbiota transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negativation of digestive tract colonization
Negativation of the rectal swab performed, free from CRE or GRE
Measured: At one week, 2 weeks, one month up to 6 months
Secondary outcomes (1)
Metagenomics profile between donor and recipient depending on decolonization
Study with a universal super donor in order to improve efficacy
Measured: At one week, 2 weeks, one month up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start1 Nov 2014
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study of patients colonized by either CRE or GRE will be enrolled in order to evaluate the impact of fecal microbiota transplant on the eradication of XDR bacteria colonization
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin DAVIDO, Centre d'Investigation Clinique et Technologique 805
- Investigators
- Benjamin Davido, MD, MS, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029078
- Sponsor's protocol ID
- GIPIT002
- Other IDs
- 2014-003048-11, 2014
- Acronym
- FEDEX
- Status last verified
- Jul 2021
- First submitted
- 20 Jan 2017
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FEcal Transplant, a Hope to Eradicate Colonization of Patient Harboring eXtreme Drug Resistant Bacteria?
- ClinicalTrials.gov ID
- NCT03029078
- Acronym / sponsor ID
- FEDEX / GIPIT002
- Keywords
- XDR, fecal microbiota transplant, eradicate, colonization, CRE, GRE, bacteria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our trial try to eradicate digestive tract colonization of patient harboring Extreme Drug Resistant (XDR) bacteria by performing a fecal transplantation.
Detailed description
Main objective:
Evaluate the eradication of the colonization of patient harboring XDR bacteria after a fecal transplantation from a healthy donor.
Secondary objectives:
English Evaluate the side effects of this procedure and tolerability. Evaluate the efficacy of the transplant if the patient is harboring glycopeptid resistant enteroccus (GRE) or carbapenem resistant enterobacteriae (CRE)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study of patients colonized by either CRE or GRE will be enrolled in order to evaluate the impact of fecal microbiota transplant on the eradication of XDR bacteria colonization
| Arm | Type | Receives |
|---|---|---|
| Fecal transplantation | Experimental | Drug: fecal microbiota transplantPatient will be transplanted with a healthy donor microbiota, free from XDR bacteria, in order to evaluate the impact on the digestive tract colonization Whole process of feces screening and reconstitution was under the responsibility of the pharmacists in charge of the study. Patient will benefit of a naso-duodenal tube in order to perform a bowel lavage prio to the fecal microbiota transplant. Patient will be monitored for 24h to rule out potential adverse events. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient harboring a VRE or CRE bacteria
- Colonization confirmed by our microbiology department, including at least 3 positives swabs in the last month
Key exclusion criteria (4 listed)
- Pregnant woman or breastfeeding
- immunosuppression including AIDS, corticosteroids over 60mg/day
- ongoing antibiotic treatment at the day of inclusion
- impossibility to obtain a signed consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fecal microbiota transplantAlso: FEDEXWe will perform a fecal microbiota transplant for patients harboring XDR bacteria in their digestive tract | Drug | Fecal transplantation |
Primary outcome
Negativation of digestive tract colonization
Time frame: At one week, 2 weeks, one month up to 6 months
Negativation of the rectal swab performed, free from CRE or GRE
1 secondary outcome
Metagenomics profile between donor and recipient depending on decolonization
Time frame: At one week, 2 weeks, one month up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Davido, MD, MS principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fecal microbiota transplant in people with Microbial Colonization and Bacterial Peritonitis, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negativation of digestive tract colonization (time frame: At one week, 2 weeks, one month up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.