Study Stopped
Low enrollment was exacerbated by a covid policy related study suspension so the research was stopped.
Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
FMT
1 other identifier
interventional
24
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2015
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 16, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2021
CompletedResults Posted
Study results publicly available
March 24, 2022
CompletedMarch 24, 2022
February 1, 2022
5.4 years
April 1, 2015
January 3, 2022
February 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
within 6 months of ileo-cecal resection
Secondary Outcomes (3)
Change in Microbial Diversity: Shannon Diversity Index
baseline, 4, 12, and 26 weeks
Number of Participants in Clinical Remission at 26 Weeks
26 weeks
Adverse Events Frequency
4, 12, and 26 weeks
Study Arms (2)
Fecal Microbiota Transplant (FMT)
EXPERIMENTALFecal Microbiota Transplant (FMT) via colonoscopy
Control
NO INTERVENTIONNo Fecal Microbiota Transplant (FMT) via colonoscopy
Interventions
Fecal Microbiota Transplant (FMT)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Medical Centerlead
- Brigham and Women's Hospitalcollaborator
- Beth Israel Deaconess Medical Centercollaborator
- Massachusetts Institute of Technologycollaborator
Study Sites (2)
Boston Medical Center
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Low enrollment was exacerbated by a covid policy related study suspension so the research was stopped.
Results Point of Contact
- Title
- Alan Moss, MD, PhD
- Organization
- Boston Medical Center and BU School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Alan C Moss, MD PhD
Boston Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2015
First Posted
April 16, 2015
Study Start
September 1, 2015
Primary Completion
February 4, 2021
Study Completion
February 4, 2021
Last Updated
March 24, 2022
Results First Posted
March 24, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share