Crohn's DiseasePhase 2FMTNCT02417974
Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
A Phase 2 study testing Fecal Microbiota Transplant (FMT) in people with Crohn's Disease, run by Boston Medical Center at 2 sites in United States.
Trial summary
The objective of this trial is to assess if Fecal Microbiota Therapy (FMT) can reduce the risk of endoscopic recurrence of Crohn's disease (CD) in patients after intestinal resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Fecal Microbiota Transplant (FMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2015to 4 Feb 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age > 18)
- Confirmed diagnosis of Crohn's disease (CD), based on endoscopy, histology and imaging (confirmed by Study PI for each site)
- Ileo-cecal resection or terminal ileal resection for CD within 30 days prior to enrollment
- Resection margins \& anastomosis free of active inflammation based on histology and surgical description (confirmed by Study PI for each site)
- No therapy to prevent post-operative recurrence of CD. A 30-day wash-out period for anti- tumor necrosis factors (TNF)s, thiopurines, antibiotics will be required prior to enrollment.
Who cannot join
- Diagnosis of indeterminate colitis
- Women who are pregnant or nursing
- Patients who are unable to give informed consent
- Patients who are unable or unwilling to undergo colonoscopy with moderate sedation (>ASA class II)
- Patients who have previously undergone FMT
- Patients who have a confirmed malignancy or cancer
Show all 12Show fewer
- Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
- Probiotic use within 30 days of start date
- Decompensated cirrhosis
- Congenital or acquired immunodeficiencies
- Chronic kidney disease as defined by a GFR <60mL/min/1.73m2 44
- History of rheumatic heart disease, endocarditis, or valvular disease due to risk of bacteremia from colonoscopy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Medical Center
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The objective of this trial is to assess if Fecal Microbiota Therapy (FMT) can reduce the risk of endoscopic recurrence of Crohn's disease (CD) in patients after intestinal resection. The specific outcomes of FMT to be examined are: 1) endoscopic appearance, 2) clinical symptoms, 3) safety and tolerability, and 4) microbial diversity. The research team hypothesizes that FMT will prevent establishment of "pro-inflammatory" microbiome after surgery, leading to a reduced probability of recurrence of macroscopic inflammation. It is also hypothesized that FMT will be safe and well-tolerated in these patients.
- Conditions
- Crohn's Disease
- Being tested
- Fecal Microbiota Transplant (FMT)
- Keywords
- Prevention, Recurrence, Fecal Microbiota Therapy
- Medical subject headings
- Crohn Disease, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplant (FMT)Biological
Also called Fecal Transplant, Stool Transplant
Fecal Microbiota Transplant (FMT)
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Transplant (FMT) | Experimental | Fecal Microbiota Transplant (FMT) via colonoscopy Receives: Biological: Fecal Microbiota Transplant (FMT) |
| Control | No intervention | No Fecal Microbiota Transplant (FMT) via colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Endoscopic Recurrence
Percentage of patients in each arm of the trial who develop endoscopic recurrence within 6 months of ileo-cecal resection. "Endoscopic recurrence" will be defined as a Rutgeert's score of greater than i2
Measured: within 6 months of ileo-cecal resection
Secondary outcomes (3)
Change in Microbial Diversity: Shannon Diversity Index
The Shannon Diversity Index is a measure of entropy and is a function of the distribution of the total number of organisms across all of the species. If S is the total number of species in the sample and p_i is the number of organisms in the i-th species divided by the total number of organisms, then Diversity = -Σ p_i log(p_i). Lower values indicate more diversity while higher values indicate less diversity.
Measured: baseline, 4, 12, and 26 weeks
Number of Participants in Clinical Remission at 26 Weeks
Clinical remission is defined as having a Harvey Bradshaw Index (HBI) score <5 at week 26. The HBI can range from 0 to 18 and higher scores are associated with more severe disease.
Measured: 26 weeks
Adverse Events Frequency
Number of participants with adverse events
Measured: 4, 12, and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startSep 2015
- Primary completion4 Feb 2021
- Study completion4 Feb 2021
Why it stopped: Low enrollment was exacerbated by a covid policy related study suspension so the research was stopped.
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 Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Massachusetts Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Alan C Moss, MD PhD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417974
- Sponsor's protocol ID
- H-34244
- Acronym
- FMT
- Status last verified
- Feb 2022
- First submitted
- 1 Apr 2015
- Last updated
- 24 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
- ClinicalTrials.gov ID
- NCT02417974
- Acronym / sponsor ID
- FMT / H-34244
- Conditions
- Crohn's Disease
- Keywords
- Prevention, Recurrence, Fecal Microbiota Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment was exacerbated by a covid policy related study suspension so the research was stopped.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Massachusetts Institute of Technology
- Study start
- Sep 2015 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 16 Apr 2015 (estimated)
- Results
- Posted 24 Mar 2022
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 trial is to assess if Fecal Microbiota Therapy (FMT) can reduce the risk of endoscopic recurrence of Crohn's disease (CD) in patients after intestinal resection. The specific outcomes of FMT to be examined are: 1) endoscopic appearance, 2) clinical symptoms, 3) safety and tolerability, and 4) microbial diversity. The research team hypothesizes that FMT will prevent establishment of "pro-inflammatory" microbiome after surgery, leading to a reduced probability of recurrence of macroscopic inflammation. It is also hypothesized that FMT will be safe and well-tolerated in these patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbiota Transplant (FMT) | Experimental | Biological: Fecal Microbiota Transplant (FMT)Fecal Microbiota Transplant (FMT) via colonoscopy |
| Control | No intervention | –No Fecal Microbiota Transplant (FMT) via colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (age > 18)
- Confirmed diagnosis of Crohn's disease (CD), based on endoscopy, histology and imaging (confirmed by Study PI for each site)
- Ileo-cecal resection or terminal ileal resection for CD within 30 days prior to enrollment
- Resection margins \& anastomosis free of active inflammation based on histology and surgical description (confirmed by Study PI for each site)
- No therapy to prevent post-operative recurrence of CD. A 30-day wash-out period for anti- tumor necrosis factors (TNF)s, thiopurines, antibiotics will be required prior to enrollment.
Key exclusion criteria (12 listed)
- Diagnosis of indeterminate colitis
- Women who are pregnant or nursing
- Patients who are unable to give informed consent
- Patients who are unable or unwilling to undergo colonoscopy with moderate sedation (>ASA class II)
- Patients who have previously undergone FMT
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 Transplant (FMT)Also: Fecal Transplant, Stool TransplantFecal Microbiota Transplant (FMT) | Biological | Fecal Microbiota Transplant (FMT) |
Primary outcome
Post-operative Endoscopic Recurrence
Time frame: within 6 months of ileo-cecal resection
Percentage of patients in each arm of the trial who develop endoscopic recurrence within 6 months of ileo-cecal resection. "Endoscopic recurrence" will be defined as a Rutgeert's score of greater than i2
3 secondary outcomes
Change in Microbial Diversity: Shannon Diversity Index
Time frame: baseline, 4, 12, and 26 weeks
Number of Participants in Clinical Remission at 26 Weeks
Time frame: 26 weeks
Adverse Events Frequency
Time frame: 4, 12, and 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- 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.
Alan C Moss, MD PhD principal investigator
Boston Medical Center
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 Fecal Microbiota Transplant (FMT) in people with Crohn's Disease, run by Boston Medical Center 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 5 inclusion and 12 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 24 Mar 2022. 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. 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 24 Mar 2022). 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?
Post-operative Endoscopic Recurrence (time frame: within 6 months of ileo-cecal resection). 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 24 Mar 2022.