Antibiotic Resistant StrainPhase 2NCT03063437
A Trial of Encapsulated Fecal Microbiota for Vancomycin Resistant Enterococcus Decolonization
A Phase 2 study testing Encapsulated fecal microbiota preparation in people with Antibiotic Resistant Strain, run by Microbiome Health Research Institute at 2 sites in United States.
Trial summary
The objective of this study is to provide preliminary insight into the safety and efficacy of fecal microbiota transplantation (FMT) for the eradication of gastrointestinal carriage of vancomycin-resistant Enterococcus. 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?
- Encapsulated fecal microbiota preparation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Aug 2017to 26 Feb 2019
- Phase
- Phase 2
- 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
- Adults 18 years or older at the time of enrollment.
- Able to provide signed and dated informed consent.
- Identified as VRE-positive by a stool culture within last 14 days.
- Women of childbearing potential in sexual relationships with men must use an acceptable method of contraception§ from 30 days prior to enrollment until 4 weeks after completing study treatment.
- Males must agree to avoid impregnation of women during and for four weeks after completing study treatment through use of an acceptable method of contraception*.
- Includes, but is not limited to, barrier with additional spermicidal foam or jelly, intrauterine device, hormonal contraception (started at least 30 days prior to study enrollment), intercourse with men who underwent vasectomy.
- Includes, but is not limited to, barrier with additional spermicidal foam or jelly and vasectomy.
Who cannot join
- Female patient who are pregnant, lactating or planning on becoming pregnant during study. Female patients of childbearing potential will undergo a pregnancy test, and be excluded from the study if positive.
- Inability (e.g. dysphagia) to or unwilling to swallow capsules.
- Active antibiotic resistant bacteria (ARB) or gastrointestinal infection at time of enrollment.
- Patient received antibiotics in the last 48 hours. Patients will be eligible to enroll if antibiotic therapy is discontinued for at minimum 48 hours prior to randomization. Does not include antibiotics used for prophylaxis or topical antibiotics.
- Requires continued antibiotic use or anticipates antibiotic use in the upcoming 4 weeks. Does not include antibiotics used for prophylaxis or topical antibiotics.
- Unwilling to withhold probiotics for a minimum of 48 hours prior to providing a screening stool sample.
Show all 19Show fewer
- Known or suspected toxic megacolon and/or known small bowel ileus.
- Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy.
- History of total colectomy or bariatric surgery.
- Admitted to or expected to an intensive care unit for medical reasons (not just boarding). Patients residing in a nursing home, long-term care facility or rehabilitation center may be enrolled.
- Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy. Patients on maintenance chemotherapy may be enrolled only after consultation with medical monitor.
- Unable or unwilling to comply with protocol requirements.
- Expected life expectancy < 6 months
- Previous FMT or microbiome-based products at any time excluding this study.
- Patients with a history of severe anaphylactic or anaphylactoid food allergy.
- Solid organ transplant recipients ≤ 90 days post-transplant or on active treatment for rejection.
- Neutropenia (≤500 neutrophils/mL) or other severe immunosuppression. Anti-TNF will be permitted. Patients on monoclonal antibodies to B and T cells. glucocorticoids, antimetabolites (azathioprine, 6-mercaptopurine, methotrexate), calcineurin inhibitors (tacrolimus, cyclosporine) and mycophenolate mofetil may be enrolled only after consultation with the medical monitor.
- If at risk for CMV/EBV associated disease (at investigator's discretion, e.g. immunocompromised), negative IgG testing for cytomegalovirus (CMV) or Epstein Barr Virus (EBV).
- A condition that would jeopardize the safety or rights of the subject, would make it unlikely for the subject to complete the study, or would confound the results of the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
IU Health University Hospital
Indianapolis, Indiana, 46202
University of Wisconsin University Hospital
Madison, Wisconsin, 53792
About this study
Official title: Phase II Randomized, Double Blind, Placebo-controlled, Parallel Group Trial of Encapsulated Fecal Microbiota Transplantation for Vancomycin Resistant Enterococcus Decolonization
The objective of this study is to provide preliminary insight into the safety and efficacy of fecal microbiota transplantation (FMT) for the eradication of gastrointestinal carriage of vancomycin-resistant Enterococcus.
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
- Encapsulated fecal microbiota preparation, Encapsulated placebo
- Keywords
- vancomycin resistant enterococcus, VRE, decolonization, VRE colonization, fecal microbiota transplantation, FMT, FMT capsule, capsule, antimicrobial resistance, antibiotic resistance, MDRO, multidrug-resistant organism, OpenBiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encapsulated fecal microbiota preparationBiological
30 capsules
Encapsulated placeboBiological
30 capsules
| Study group | Role | What they receive |
|---|---|---|
| Active: Encapsulated Fecal Microbiota Preparation | Experimental | Single dose of oral, encapsulated fecal microbiota preparation (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months. Receives: Biological: Encapsulated fecal microbiota preparation |
| Placebo: Encapsulated Placebo | Placebo comparator | Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, and 28 days, and 6 months. Receives: Biological: Encapsulated placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With VRE Decolonization
VRE decolonization is defined by absence of VRE on stool culture using standard clinical laboratory techniques at Day 10 (± 3 days) after randomization.
Measured: Day 10 (±3 days) after randomization
Percentage of Participants With an Adverse Event (AE); Severe Adverse Event (SAE); and Newly Acquired Transmissible Infectious Diseases Which Are Considered Adverse Events of Special Interest (AESI)
Percentage of participants with an adverse event (AE); severe adverse event (SAE); and newly acquired transmissible infectious diseases which are considered adverse events of special interest (AESI) through Day 10 (± 3 days) after randomization.
Measured: Day 10 (±3 days) after randomization
Secondary outcomes (9)
Percentage of Participants With VRE Infection
Percentage of participants with VRE infection, defined as an associated bacteremia, urinary tract infection, or wound-related infection.
Measured: Week 4 (±5 days) after randomization
Percentage of Participants With ARB Colonization on Day 10 Following Fecal Microbiota Transplantation (FMT)
Percentage of participants with other antibiotic resistant bacteria (ARB) colonization
Measured: Day 10 (± 3 days) after randomization
Percentage of Participants With ARB Infection 4 Weeks Following FMT
Percentage of participants with composite ARB infection
Measured: Week 4 (±5 days) after randomization
Number of Days Between FMT and VRE Colonization and Infection Occurs
Time (in days) from randomization until the study day when VRE colonization and infection occurs
Measured: Up to 6 months after randomization
VRE Decolonization Among Immunocompromised Patients
Percentage of participants with VRE decolonization among immunocompromised patients
Measured: Day 10 (± 3 days) after randomization
Adverse Events Within 4 Weeks Following FMT
Percentage of participants with an adverse event (AE)
Measured: Week 4 (±5 days) after randomization
Serious Adverse Events Within 4 Weeks Following FMT
Percentage of participants with a serious adverse event (SAE)
Measured: Week 4 (±5 days) after randomization
Newly Acquired Transmissible Infectious Diseases Which Are Considered Adverse Events of Special Interest (AESI)
Percentage of participants with newly acquired transmissible infectious diseases which are considered adverse events of special interest (AESI)
Measured: Week 4 (±5 days) after randomization
Serious Adverse Events Within 6 Months Following FMT
Percentage of participants with a Serious Adverse Event (SAE)
Measured: Month 6 (±14 days) phone safety assessment after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start17 Aug 2017
- Primary completion19 Sep 2018
- Study completion26 Feb 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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microbiome Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison, Indiana University
- 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
- NCT03063437
- Sponsor's protocol ID
- 200-2016-91948
- Status last verified
- Apr 2020
- First submitted
- 17 Feb 2017
- Last updated
- 13 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized, Double Blind, Placebo-controlled, Parallel Group Trial of Encapsulated Fecal Microbiota Transplantation for Vancomycin Resistant Enterococcus Decolonization
- ClinicalTrials.gov ID
- NCT03063437
- Acronym / sponsor ID
- 200-2016-91948
- Conditions
- Antibiotic Resistant Strain
- Keywords
- vancomycin resistant enterococcus, VRE, decolonization, VRE colonization, fecal microbiota transplantation, FMT, FMT capsule, capsule
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Microbiome Health Research InstituteUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison, Indiana University
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- 19 Sep 2018 (actual)
- Study completion
- 26 Feb 2019 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to provide preliminary insight into the safety and efficacy of fecal microbiota transplantation (FMT) for the eradication of gastrointestinal carriage of vancomycin-resistant Enterococcus.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active: Encapsulated Fecal Microbiota Preparation | Experimental | Biological: Encapsulated fecal microbiota preparationSingle dose of oral, encapsulated fecal microbiota preparation (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months. |
| Placebo: Encapsulated Placebo | Placebo comparator | Biological: Encapsulated placeboSingle dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, and 28 days, and 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults 18 years or older at the time of enrollment.
- Able to provide signed and dated informed consent.
- Identified as VRE-positive by a stool culture within last 14 days.
- Women of childbearing potential in sexual relationships with men must use an acceptable method of contraception§ from 30 days prior to enrollment until 4 weeks after completing study treatment.
- Males must agree to avoid impregnation of women during and for four weeks after completing study treatment through use of an acceptable method of contraception*.
Key exclusion criteria (19 listed)
- Female patient who are pregnant, lactating or planning on becoming pregnant during study. Female patients of childbearing potential will undergo a pregnancy test, and be excluded from the study if positive.
- Inability (e.g. dysphagia) to or unwilling to swallow capsules.
- Active antibiotic resistant bacteria (ARB) or gastrointestinal infection at time of enrollment.
- Patient received antibiotics in the last 48 hours. Patients will be eligible to enroll if antibiotic therapy is discontinued for at minimum 48 hours prior to randomization. Does not include antibiotics used for prophylaxis or topical antibiotics.
- Requires continued antibiotic use or anticipates antibiotic use in the upcoming 4 weeks. Does not include antibiotics used for prophylaxis or topical antibiotics.
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 |
|---|---|---|
| Encapsulated fecal microbiota preparation30 capsules | Biological | Active: Encapsulated Fecal Microbiota Preparation |
| Encapsulated placebo30 capsules | Biological | Placebo: Encapsulated Placebo |
Primary outcome
Percentage of Participants With VRE Decolonization
Time frame: Day 10 (±3 days) after randomization
VRE decolonization is defined by absence of VRE on stool culture using standard clinical laboratory techniques at Day 10 (± 3 days) after randomization.
Percentage of Participants With an Adverse Event (AE); Severe Adverse Event (SAE); and Newly Acquired Transmissible Infectious Diseases Which Are Considered Adverse Events of Special Interest (AESI)
Time frame: Day 10 (±3 days) after randomization
Percentage of participants with an adverse event (AE); severe adverse event (SAE); and newly acquired transmissible infectious diseases which are considered adverse events of special interest (AESI) through Day 10 (± 3 days) after randomization.
9 secondary outcomes
Percentage of Participants With VRE Infection
Time frame: Week 4 (±5 days) after randomization
Percentage of Participants With ARB Colonization on Day 10 Following Fecal Microbiota Transplantation (FMT)
Time frame: Day 10 (± 3 days) after randomization
Percentage of Participants With ARB Infection 4 Weeks Following FMT
Time frame: Week 4 (±5 days) after randomization
Number of Days Between FMT and VRE Colonization and Infection Occurs
Time frame: Up to 6 months after randomization
VRE Decolonization Among Immunocompromised Patients
Time frame: Day 10 (± 3 days) after randomization
Adverse Events Within 4 Weeks Following FMT
Time frame: Week 4 (±5 days) after randomization
Serious Adverse Events Within 4 Weeks Following FMT
Time frame: Week 4 (±5 days) after randomization
Newly Acquired Transmissible Infectious Diseases Which Are Considered Adverse Events of Special Interest (AESI)
Time frame: Week 4 (±5 days) after randomization
Serious Adverse Events Within 6 Months Following FMT
Time frame: Month 6 (±14 days) phone safety assessment after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Encapsulated fecal microbiota preparation in people with Antibiotic Resistant Strain, run by Microbiome Health Research Institute at 2 sites 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 7 inclusion and 19 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 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 5 Feb 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?
Percentage of Participants With VRE Decolonization (time frame: Day 10 (±3 days) after randomization). The study lists 2 primary outcomes in all. 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 13 Apr 2020.