Multi-antibiotic ResistanceNCT02906774
Fecal Transplant for MDR Pathogen Decolonization
An observational study of Multi-antibiotic Resistance, run by University of British Columbia at 1 site in Canada.
Trial summary
This is a proof-of-principle research study designed to determine whether fecal microbiota transplantation (FMT) can eliminate highly drug-resistant bacteria from the intestinal tract of renal transplant patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Multi-antibiotic Resistance
- What is being tested?
- Fecal microbiota transplantation (FMT)
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to Nov 2019
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Renal transplant patients who are intestinally colonized with any of the target MDR organisms based on rectal culture screening according to Provincial Infection Control Network of British Columbia guidelines and performed by the Vancouver General Hospital Clinical Laboratory will be eligible.
Renal transplant patient inclusion criteria:
- 18 years or older
- Able to provide informed consent
- Positive for one of the target MDR organisms by rectal or stool culture tests
FMT stool donor inclusion criteria:
- Able to provide informed consent
- Able to complete donor screening
- Able to adhere to FMT stool collection and testing procedures
Renal transplant patient exclusion criteria:
- Still in hospital at week 7 following organ transplantation
- Pregnant or planning to become pregnant
- Breastfeeding
- Participating in another interventional or investigational study
- Neutropenic (ANC < 0.5)
- Colonized with Clostridium difficile
- Presence of colostomy or ileostomy
- Has an active intestinal infection
- Fever > 38.0 or WBC count > 15,000
- Are taking a non-dietary probiotic supplement
- Require or are expected to require systemic antimicrobial therapy other than Pneumocystis prophylaxis or cytomegalovirus (CMV) therapy during the study period
- Has a severe underlying disease with anticipated survival less than 6 months
- Are unable to tolerate FMT or enema for any reason, or where their physician believes for any reason that FMT might pose a health risk to the subject
- Subjects who report a history of anaphylactoid food allergy will not be excluded but these allergies will be noted and donors will be required to avoid ingestion of these foods for at least three days prior to donation
FMT stool donor exclusion criteria:
- Presence of any of the following by stool examination: vancomycin-resistant Enterococci (VRE), Salmonella, Shigella, shiga toxin-producing E. coli, Yersinia, Campylobacter, ESBL or carbapenemase-producing Enterobacteriaceae (CRE), pathogenic ova or parasites, C. difficile toxin B (by PCR), or rotavirus, adenovirus and norovirus
- History of any type of active cancer aside from melanoma
- Risk factors for acquisition of HIV, syphilis, Hepatitis B, Hepatitis C, prion or any neurological disease as determined by the donor questionnaire
- History of gastrointestinal comorbidities, e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation or diarrhea, or colostomy or ileostomy
- Receipt of blood transfusion from a country other than Canada in the preceding 6 months
- Antibiotic use or any systemic immunosuppressive agents in the 3 months prior to stool donation
- Receipt of any live vaccine within 3 months prior to stool donation
- Any current or previous medical or psychosocial condition or behaviors which in the opinion of the investigator may pose risk to the recipients or the donor
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T 1Z9
About this study
Official title: A Prospective, Case-series Study of Fecal Microbiota Transplantation for the Selective Intestinal Decolonization of Multidrug-resistant, Pathogenic Enterobacteriaceae
This is a proof-of-principle research study designed to determine whether fecal microbiota transplantation (FMT) can eliminate highly drug-resistant bacteria from the intestinal tract of renal transplant patients. The primary goal of this study is to test whether oral gut decontamination followed by FMT by enema delivery will result in decolonization of the intestinal tract of renal transplant patients shortly after solid organ transplantation, thereby preventing difficult to treat post-transplant infections.
Read the detailed description
Contact the study principal investigator for the study protocol.
- Conditions
- Multi-antibiotic Resistance
- Being tested
- Fecal microbiota transplantation (FMT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantation (FMT)Biological
Fecal microbiota transplantation after antibiotic pretreatment
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the study will be the proportion of successfully decolonized patients out of all study patients evaluated, defined as the sustained elimination of a MDR target organism over a minimum of ≥ 2 study visits.
Measured: 6 months
Secondary outcomes (2)
Determine the number of patients with treatment-related adverse events, as defined by the study adverse event questionnaire (including the Common Terminology Criteria for Adverse Events (v4.0)).
Measured: 6 months
Estimate the proportion of patients who become re-colonized following FMT.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2019
- Study completionNov 2019
Why it stopped: This observational study has been transitioned to a clinical trial and is now registered at (NCT04181112).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi-antibiotic ResistanceStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amee Manges, University of British Columbia
- Investigators
- Amee Manges, MPH, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906774
- Sponsor's protocol ID
- H15-01944
- Status last verified
- Nov 2019
- First submitted
- 8 Aug 2016
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Case-series Study of Fecal Microbiota Transplantation for the Selective Intestinal Decolonization of Multidrug-resistant, Pathogenic Enterobacteriaceae
- ClinicalTrials.gov ID
- NCT02906774
- Acronym / sponsor ID
- H15-01944
- Conditions
- Multi-antibiotic Resistance
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This observational study has been transitioned to a clinical trial and is now registered at (NCT04181112).
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 20 Sep 2016 (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.
This is a proof-of-principle research study designed to determine whether fecal microbiota transplantation (FMT) can eliminate highly drug-resistant bacteria from the intestinal tract of renal transplant patients. The primary goal of this study is to test whether oral gut decontamination followed by FMT by enema delivery will result in decolonization of the intestinal tract of renal transplant patients shortly after solid organ transplantation, thereby preventing difficult to treat post-transplant infections.
Detailed description
Contact the study principal investigator for the study protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Renal transplant patients who are intestinally colonized with any of the target MDR organisms based on rectal culture screening according to Provincial Infection Control Network of British Columbia guidelines and performed by the Vancouver General Hospital Clinical Laboratory will be eligible.
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 transplantation (FMT)Fecal microbiota transplantation after antibiotic pretreatment | Biological | – |
Primary outcome
The primary outcome of the study will be the proportion of successfully decolonized patients out of all study patients evaluated, defined as the sustained elimination of a MDR target organism over a minimum of ≥ 2 study visits.
Time frame: 6 months
2 secondary outcomes
Determine the number of patients with treatment-related adverse events, as defined by the study adverse event questionnaire (including the Common Terminology Criteria for Adverse Events (v4.0)).
Time frame: 6 months
Estimate the proportion of patients who become re-colonized following FMT.
Time frame: 6 months
Results and safety
The study was stopped early (reason given: This observational study has been transitioned to a clinical trial and is now registered at (NCT04181112).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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.
Amee Manges, MPH, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multi-antibiotic Resistance, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 2 Dec 2019. 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 Canada. 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.
Are results available for this study?
The study was stopped early (reason given: This observational study has been transitioned to a clinical trial and is now registered at (NCT04181112).). Results are not available in the source record.
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?
The primary outcome of the study will be the proportion of successfully decolonized patients out of all study patients evaluated, defined as the sustained elimination of a MDR target organism over a minimum of ≥ 2 study visits. (time frame: 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 2 Dec 2019.