Clostridium DifficilePhase 2STOOLNCT02403622
Safety of FMT: OpenBiome Outcomes and Longitudinal Follow-up (STOOL) for Recurrent Clostridium Difficile Infection
A Phase 2 study testing Fecal Microbiota Preparation in people with Clostridium Difficile, run by Microbiome Health Research Institute at 4 sites in United States.
Trial summary
The overarching objective of this study is to address the knowledge gap regarding the short-term and long-term safety of fecal microbiota transplants (FMT). The design will be a prospective, open-label, multi-center longitudinal cohort study to assess the short- and long-term safety of FMT as well as the clinical… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Clostridium Difficile
- What is being tested?
- Fecal Microbiota Preparation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2015to Jun 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (age 18-75 years old)
- Outpatient
- Third or further documented CDI episode and
- Unable to maintain CDI cure after standard therapy with oral vancomycin or fidaxomicin
- Previous treatment with at least one course of tapered/pulse vancomycin or
- Inability to taper or stop vancomycin or fidaxomicin without developing diarrhea requiring antibiotic therapy.
- Improvement of CDI symptoms on vancomycin or fidaxomicin
Who cannot join
- Unable to comply with study follow-up procedures at discretion of MD
- Unable to provide informed consent at discretion of MD
- Participating in another clinical trial
- Pregnant or nursing currently or planned pregnancy in next 1 year
- Evidence of toxic megacolon or gastrointestinal perforation
- Peripheral white blood cell count >30 x 10^9/L and/or temperature >38 degrees Celsius
Show all 32Show fewer
- Admission to an intensive care unit within prior 7 days for any reason
- Previously undergone FMT
- Severely immunocompromised patients
- HIV infection (any CD4 count)
- AIDS-defining diagnoses
- Inherited/primary immune disorder
- Immunosuppressant medications:
- Current or recent (<3 months) treatment with anti-neoplastic agents
- Current or recent (<3 months) treatment with calcineurin inhibitors (tacrolimus, cyclosporine)
- Current or recent (<3 months) treatment with mycophenolate mofetil
- Current or recent (<3 months) treatment with monoclonal antibodies to B and T-Cells, anti-TNF, glucocorticoids, antimetabolites (azathioprine, 6-mercaptopurine)
- Neutropenia with absolute neutrophil count (ANC) <0.5 x 10^9/L
- Active gastroenteritis due to infectious cause other than CDI
- Short gut syndrome
- Colostomy
- Ascites
- End-stage liver disease
- Untreated, in-situ colorectal cancer
- Irritable bowel syndrome
- Inflammatory bowel disease including Crohn's disease and ulcerative colitis
- Microscopic colitis including collagenous colitis and lymphocytic colitis
- Severe food allergy (anaphylaxis) that cannot be confirmed as having been excluded from a donor's diet within the five days prior to donation
- Anorectal disorder/severe rectal sphincter tone abnormality or inability to retain enema material
- Unable or unwilling to tolerate colonoscopy/sigmoidoscopy, colonoscopy prep, or enema for any reason at discretion of MD
- Severe underlying disease that the patient is not expected to survive for the subsequent 12 months at the discretion of the MD.
- Any conditions for which, in opinion of MD, the treatment may pose a health risk
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Tufts Medical Center
Boston, Massachusetts, 02108
IU University Hospital
Indianapolis, Indiana, 46202
Edward Hospital
Naperville, Illinois, 60540
Brown University
Providence, Rhode Island, 02904
About this study
Official title: Safety of Fecal Microbiota Transplantation: OpenBiome Outcomes and Longitudinal Follow-up (STOOL) for Recurrent Clostridium Difficile Infection
The overarching objective of this study is to address the knowledge gap regarding the short-term and long-term safety of fecal microbiota transplants (FMT). The design will be a prospective, open-label, multi-center longitudinal cohort study to assess the short- and long-term safety of FMT as well as the clinical resolution of diarrhea among 150 patients with 3 or more episodes of clostridium difficile infection (CDI defined as 3 unformed stools over 24 hours for 2 consecutive days and either a positive stool test for CDI or pseudomembranes on colonoscopy/sigmoidoscopy). Subjects will be adult outpatients referred to one of the study centers after at least three recurrent episodes of CDI and previous treatment with at least one 10-day course of oral vancomycin or fidaxomicin. After FMT by colonoscopy/sigmoidoscopy or enema, patients will be followed prospectively and monitored for clinical resolution and adverse events at: 3 days (telephone), 3 weeks (clinical assessment), 8 weeks (telephone), 6 months (telephone), and 12 months (telephone) after FMT. Subjects who recur will be offered a second FMT by colonoscopy with a different donor. Microbiome analysis will be conducted from stool samples at baseline and each of the 5 follow-up intervals.
- Conditions
- Clostridium Difficile
- Being tested
- Fecal Microbiota Preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota PreparationDrug
Frozen processed human fecal material for treating recurrent Clostridium difficile infections.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Fecal Microbiota Preparation | Experimental | Open label single arm Dosage form: Screened human donor stool, sourced from human-derived microbes generated by healthy, screened donors.
Route of administration: either colonoscopic/sigmoidoscopic FMT or retention enema FMT Dosing Regimen: 250 mL x 1 dose. In the event of a clinical non-response, a repeat single 250 mL dose will occur from a different donor Receives: Drug: Fecal Microbiota Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term Safety of FMT as Measured by Absence or Presence of Related Serious Adverse Events
Determine the short-term safety of FMT for the prevention of further CDI recurrence. Short-term safety was measured by absence or presence of related serious adverse events
Measured: < 6 weeks post FMT
Long-term Safety of FMT as Measured by Absence or Presence of Adverse Events
Determine the long-term safety of FMT for the prevention of further CDI recurrence
Measured: > 6 weeks to 1 year post FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2017
- Study completionJun 2018
Why it stopped: for futility
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 Clostridium DifficileStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microbiome Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, Edward Hospital, Indiana University, Tufts Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403622
- Sponsor's protocol ID
- 1410006671
- Acronym
- STOOL
- Status last verified
- Feb 2021
- First submitted
- 6 Mar 2015
- Last updated
- 23 Feb 2021
- 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 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Fecal Microbiota Transplantation: OpenBiome Outcomes and Longitudinal Follow-up (STOOL) for Recurrent Clostridium Difficile Infection
- ClinicalTrials.gov ID
- NCT02403622
- Acronym / sponsor ID
- STOOL / 1410006671
- Conditions
- Clostridium Difficile
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: for futility
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Microbiome Health Research InstituteUniversity, hospital or other
- Collaborators
- Brown University, Edward Hospital, Indiana University, Tufts Medical Center
- Study start
- Mar 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Posted 23 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching objective of this study is to address the knowledge gap regarding the short-term and long-term safety of fecal microbiota transplants (FMT). The design will be a prospective, open-label, multi-center longitudinal cohort study to assess the short- and long-term safety of FMT as well as the clinical resolution of diarrhea among 150 patients with 3 or more episodes of clostridium difficile infection (CDI defined as 3 unformed stools over 24 hours for 2 consecutive days and either a positive stool test for CDI or pseudomembranes on colonoscopy/sigmoidoscopy). Subjects will be adult outpatients referred to one of the study centers after at least three recurrent episodes of CDI and previous treatment with at least one 10-day course of oral vancomycin or fidaxomicin. After FMT by colonoscopy/sigmoidoscopy or enema, patients will be followed prospectively and monitored for clinical resolution and adverse events at: 3 days (telephone), 3 weeks (clinical assessment), 8 weeks (telephone), 6 months (telephone), and 12 months (telephone) after FMT. Subjects who recur will be offered a second FMT by colonoscopy with a different donor. Microbiome analysis will be conducted from stool samples at baseline and each of the 5 follow-up intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention: Fecal Microbiota Preparation | Experimental | Drug: Fecal Microbiota PreparationOpen label single arm Dosage form: Screened human donor stool, sourced from human-derived microbes generated by healthy, screened donors. Route of administration: either colonoscopic/sigmoidoscopic FMT or retention enema FMT Dosing Regimen: 250 mL x 1 dose. In the event of a clinical non-response, a repeat single 250 mL dose will occur from a different donor |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult (age 18-75 years old)
- Outpatient
- Third or further documented CDI episode and
- Unable to maintain CDI cure after standard therapy with oral vancomycin or fidaxomicin
- Improvement of CDI symptoms on vancomycin or fidaxomicin
Key exclusion criteria (32 listed)
- Unable to comply with study follow-up procedures at discretion of MD
- Unable to provide informed consent at discretion of MD
- Participating in another clinical trial
- Pregnant or nursing currently or planned pregnancy in next 1 year
- Evidence of toxic megacolon or gastrointestinal perforation
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 PreparationFrozen processed human fecal material for treating recurrent Clostridium difficile infections. | Drug | Intervention: Fecal Microbiota Preparation |
Primary outcome
Short-term Safety of FMT as Measured by Absence or Presence of Related Serious Adverse Events
Time frame: < 6 weeks post FMT
Determine the short-term safety of FMT for the prevention of further CDI recurrence. Short-term safety was measured by absence or presence of related serious adverse events
Long-term Safety of FMT as Measured by Absence or Presence of Adverse Events
Time frame: > 6 weeks to 1 year post FMT
Determine the long-term safety of FMT for the prevention of further CDI recurrence
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
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Clostridioides Difficile Infection Recurrence
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 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 Fecal Microbiota Preparation in people with Clostridium Difficile, run by Microbiome Health Research Institute at 4 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 32 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: stopped early, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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 23 Feb 2021). 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?
Short-term Safety of FMT as Measured by Absence or Presence of Related Serious Adverse Events (time frame: < 6 weeks post FMT). 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 23 Feb 2021.