Antibiotic Resistant StrainPhase 1RACENCT03061097
Autologous Fecal Microbiota Transplantation to Prevent Antibiotic Resistant Bacteria Colonization
A Phase 1 study testing Autologous fecal microbiota transplant (Auto-FMP Enema) in people with Antibiotic Resistant Strain, run by Microbiome Health Research Institute at 1 site in United States.
Trial summary
This study, a Randomized controlled trial of Autologous microbiome reconstitution to prevent Colonization by antibiotic rEsistant bacteria (RACE), seeks to investigate the safety, feasibility and the role of autologous fecal microbiota transplantation (FMT) for the prevention of antibiotic resistant bacteria (ARB)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antibiotic Resistant Strain
- What is being tested?
- Autologous fecal microbiota transplant (Auto-FMP Enema)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2017to 18 Jun 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Long-term care residents associated with Boston University-Boston Medical Center nursing home consortium
- Adults (18 years or older)
- 1) Infection requiring antimicrobial treatment at the discretion of the treating physician
Who cannot join
- Pregnant. Participants of childbearing age will undergo urine pregnancy testing
- Participant or substitute decision maker unable to provide informed consent
- Allergies to following ingredients generally recognized as safe: glycerol and sodium chloride
- Current enrollment in hospice
- Colostomy
- Unable to adhere to protocol requirements
Show all 24Show fewer
- Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines puts the participant at greater risk from FMT
- Recent travel (last six months) to high risk regions based on the International SOS Medical Risk Rating system
- Recent exposure (last six months) to unsafe drinking water
- Enrollment stool sample will be tested for ARBs and processed into autologous FMT treatment (if of qualifying size). Sample will not be collected if any of the following are true:
- Oral or intravenous antibiotic exposure within the previous 6 weeks of stool collection date (topical antibiotics will be permitted)
- Active gastrointestinal infection at stool collection
- Fever at the time of stool collection
- Currently ill or complaining of any of the following signs or symptoms of illness: fever, diarrhea, blood stools and/or vomiting
- Participants with a history of gastrointestinal (GI) illness within the past 30 days prior to enrollment stool collection, that at the discretion of the site investigator could reasonably be caused by one of the following pathogens: 1) Vibrio spp. 2) Norovirus 3) Rotovirus 4) Adenovirus 5) Shiga toxin
- Colonized with CRE (assessed by PCR or culture assay during enrollment phase)
- Colonized with VRE (assessed by PCR or culture assay during enrollment phase)
- Colonized with ESBL (assessed by PCR or culture assay during enrollment phase)
- Colonized with CDI (assessed by EIA assay on stool collected at enrollment phase)
- Treatment with antibiotics which are active against MRSA (i.e. vancomycin or linezolid) prior to randomization to FMT intervention or placebo.
- Stool culture positive for common enteric pathogens (Salmonella spp., Shigella spp., Campylobacter spp.)
- Participants who develop a GI illness with symptoms such as (but not limited to) vomiting or diarrhea within 30 days after collection of enrollment stool will be evaluated by the site investigator. If the site investigator determines that the symptoms were most likely caused by 1) Vibrio spp., 2) Norovirus, 3) Rotavirus, 4) Adenovirus, or 5) Shiga toxin, the enrollment stool will be sent out to test for these organisms. If the culture is positive for any of these organisms, the participant will be excluded from randomization
- Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines puts the participant at greater risk from FMT
- Participants who become severely immunocompromised, as defined by the investigator or treating physician, will be excluded prior to receiving intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University - Boston Medical Center nursing home consortium
Boston, Massachusetts, 02118
About this study
Official title: Randomized Controlled Trial of Autologous Microbiome Reconstitution to Prevent Colonization by Antibiotic rEsistant Bacteria
This study, a Randomized controlled trial of Autologous microbiome reconstitution to prevent Colonization by antibiotic rEsistant bacteria (RACE), seeks to investigate the safety, feasibility and the role of autologous fecal microbiota transplantation (FMT) for the prevention of antibiotic resistant bacteria (ARB) through microbiome restoration.
Read the detailed description
Note: The Protocol and Statistical Analysis Plan document contains modifications from what is on file at the FDA to reflect redactions and formatting requirements for public posting on ClinicalTrials.gov
- Conditions
- Antibiotic Resistant Strain
- Being tested
- Autologous fecal microbiota transplant (Auto-FMP Enema), Placebo Enema Preparation
- Keywords
- Autologous Fecal Microbiota Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous fecal microbiota transplant (Auto-FMP Enema)Biological
FMT is the process by which processed donor microbiota material is transplanted into recipients. The aim is to reconstitute the normal intestinal microbial flora in recipients. In this study, the fecal microbiota preparation will be made from the participant's own stool and processed into an auto-FMP enema formulation.
Placebo Enema PreparationOther
The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms.
| Study group | Role | What they receive |
|---|---|---|
| Treatment (autologous fecal microbiota preparation) | Experimental | Participants randomized into the treatment arm will receive a single dose of autologous fecal microbiota preparation (auto-FMP) via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months.
Route of Administration: Enema Dosing Regimen: 125mL x 1 dose Receives: Biological: Autologous fecal microbiota transplant (Auto-FMP Enema) |
| Placebo | Placebo comparator | Participants randomized to the placebo arm will receive a single dose of placebo FMT via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms. Receives: Other: Placebo Enema Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (NIH Grade ≥2) at Day 7 After Randomization
Number of participants with NIH Grade ≥2 adverse events at Day 7 after randomization.
Measured: Day 7 after randomization
Secondary outcomes (3)
Number of Patients With Clearance of Antibiotic Resistant Bacteria (ARB)
Number of patients with clearance of ARB among patients colonized at Day 28 by Polymerase Chain Reaction (PCR) assay or culture-based assay. ARBs are: Carbapenem-resistant Enterobacteriaceae (CRE) by PCR or culture assay, Extended spectrum beta-lactamase (ESBL)-producing organisms by PCR or culture assay, Vancomycin-resistant enterococci (VRE) by PCR or culture assay, or Clostridium difficile by PCR
Measured: Day 28 after randomization
Number of Participants Who Develop Any ARB-associated Infections
Number of participants who develop any ARB-associated infections following autologous FMT at Day 3, Day 7, Day 28, and Month 6
Measured: Day 3, Day 7, Day 28, Month 6
Number of Participants With NIH Grade ≥2 AEs at Day 28 and Month 6
Number of participants with NIH Grade ≥2 adverse events (intermediate at Day 28 and long-term at Month 6) following autologous FMT.
Measured: Day 28, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start10 Jul 2017
- Primary completion19 Dec 2018
- Study completion18 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antibiotic Resistant StrainStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microbiome Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center
- Responsible party
- Sponsor
- Investigators
- Majdi Osman, MD, MPH, Principal investigator, Microbiome Health Research Institute, (d/b/a OpenBiome)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061097
- Sponsor's protocol ID
- 200201691946
- Acronym
- RACE
- Status last verified
- Apr 2021
- First submitted
- 17 Feb 2017
- Last updated
- 5 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu CK, Seo J, Pravodelov V, Frazier S, Guy M, Concilio K, Lau-Ng R, Brandeis G, Watson J, van der Velde J, Olesen SW, Budree S, Njenga M, Kassam Z, Osman M. Pilot study of autologous fecal microbiota transplants in nursing home residents: Feasibility and safety. Contemp Clin Trials Commun. 2022 Mar 7;27:100906. doi: 10.1016/j.conctc.2022.100906. eCollection 2022 Jun.
PubMed 35299780
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Autologous Microbiome Reconstitution to Prevent Colonization by Antibiotic rEsistant Bacteria
- ClinicalTrials.gov ID
- NCT03061097
- Acronym / sponsor ID
- RACE / 200201691946
- Conditions
- Antibiotic Resistant Strain
- Keywords
- Autologous Fecal Microbiota Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Microbiome Health Research InstituteUniversity, hospital or other
- Collaborators
- Boston Medical Center
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Posted 7 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study, a Randomized controlled trial of Autologous microbiome reconstitution to prevent Colonization by antibiotic rEsistant bacteria (RACE), seeks to investigate the safety, feasibility and the role of autologous fecal microbiota transplantation (FMT) for the prevention of antibiotic resistant bacteria (ARB) through microbiome restoration.
Detailed description
Note: The Protocol and Statistical Analysis Plan document contains modifications from what is on file at the FDA to reflect redactions and formatting requirements for public posting on ClinicalTrials.gov
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment (autologous fecal microbiota preparation) | Experimental | Biological: Autologous fecal microbiota transplant (Auto-FMP Enema)Participants randomized into the treatment arm will receive a single dose of autologous fecal microbiota preparation (auto-FMP) via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. Route of Administration: Enema Dosing Regimen: 125mL x 1 dose |
| Placebo | Placebo comparator | Other: Placebo Enema PreparationParticipants randomized to the placebo arm will receive a single dose of placebo FMT via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Long-term care residents associated with Boston University-Boston Medical Center nursing home consortium
- Adults (18 years or older)
- 1) Infection requiring antimicrobial treatment at the discretion of the treating physician
Key exclusion criteria (24 listed)
- Pregnant. Participants of childbearing age will undergo urine pregnancy testing
- Participant or substitute decision maker unable to provide informed consent
- Allergies to following ingredients generally recognized as safe: glycerol and sodium chloride
- Current enrollment in hospice
- Colostomy
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 |
|---|---|---|
| Autologous fecal microbiota transplant (Auto-FMP Enema)FMT is the process by which processed donor microbiota material is transplanted into recipients. The aim is to reconstitute the normal intestinal microbial flora in recipients. In this study, the fecal microbiota preparation will be made from the participant's own stool and processed into an auto-FMP enema formulation. | Biological | Treatment (autologous fecal microbiota preparation) |
| Placebo Enema PreparationThe placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms. | Other | Placebo |
Primary outcome
Number of Participants With Adverse Events (NIH Grade ≥2) at Day 7 After Randomization
Time frame: Day 7 after randomization
Number of participants with NIH Grade ≥2 adverse events at Day 7 after randomization.
3 secondary outcomes
Number of Patients With Clearance of Antibiotic Resistant Bacteria (ARB)
Time frame: Day 28 after randomization
Number of Participants Who Develop Any ARB-associated Infections
Time frame: Day 3, Day 7, Day 28, Month 6
Number of Participants With NIH Grade ≥2 AEs at Day 28 and Month 6
Time frame: Day 28, Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35299780Liu CK, Seo J, Pravodelov V, Frazier S, Guy M, Concilio K, Lau-Ng R, Brandeis G, Watson J, van der Velde J, Olesen SW, Budree S, Njenga M, Kassam Z, Osman M. Pilot study of autologous fecal microbiota transplants in nursing home residents: Feasibility and safety. Contemp Clin Trials Commun. 2022 Mar 7;27:100906. doi: 10.1016/j.conctc.2022.100906. eCollection 2022 Jun.
- 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.
Majdi Osman, MD, MPH principal investigator
Microbiome Health Research Institute, (d/b/a OpenBiome)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous fecal microbiota transplant (Auto-FMP Enema) in people with Antibiotic Resistant Strain, run by Microbiome Health Research Institute at 1 site in United States.
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 3 inclusion and 24 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 5 May 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 United States. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adverse Events (NIH Grade ≥2) at Day 7 After Randomization (time frame: Day 7 after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03061097, which also lists 1 linked publication.
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 5 May 2021; AzTrials last refreshed its copy on 8 Nov 2026.