Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT) (FMT)
Primary Purpose
Crohn's Disease
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fecal Microbiota Transplant (FMT)
Sponsored by
About this trial
This is an interventional basic science trial for Crohn's Disease focused on measuring Prevention, Recurrence, Fecal Microbiota Therapy
Eligibility Criteria
Inclusion Criteria (Patients):
- 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.
Exclusion Criteria (Patients):
- 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
Sites / Locations
- Boston Medical Center
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Fecal Microbiota Transplant (FMT)
Control
Arm Description
Fecal Microbiota Transplant (FMT) via colonoscopy
No Fecal Microbiota Transplant (FMT) via colonoscopy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
Adverse Events Frequency
Number of participants with adverse events
Full Information
NCT ID
NCT02417974
First Posted
April 1, 2015
Last Updated
February 26, 2022
Sponsor
Boston Medical Center
Collaborators
Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Massachusetts Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT02417974
Brief Title
Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
Acronym
FMT
Official Title
Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment was exacerbated by a covid policy related study suspension so the research was stopped.
Study Start Date
September 2015 (Actual)
Primary Completion Date
February 4, 2021 (Actual)
Study Completion Date
February 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Massachusetts Institute of Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Prevention, Recurrence, Fecal Microbiota Therapy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fecal Microbiota Transplant (FMT)
Arm Type
Experimental
Arm Description
Fecal Microbiota Transplant (FMT) via colonoscopy
Arm Title
Control
Arm Type
No Intervention
Arm Description
No Fecal Microbiota Transplant (FMT) via colonoscopy
Intervention Type
Biological
Intervention Name(s)
Fecal Microbiota Transplant (FMT)
Other Intervention Name(s)
Fecal Transplant, Stool Transplant
Intervention Description
Fecal Microbiota Transplant (FMT)
Primary Outcome Measure Information:
Title
Post-operative Endoscopic Recurrence
Description
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
Time Frame
within 6 months of ileo-cecal resection
Secondary Outcome Measure Information:
Title
Change in Microbial Diversity: Shannon Diversity Index
Description
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.
Time Frame
baseline, 4, 12, and 26 weeks
Title
Number of Participants in Clinical Remission at 26 Weeks
Description
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.
Time Frame
26 weeks
Title
Adverse Events Frequency
Description
Number of participants with adverse events
Time Frame
4, 12, and 26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (Patients):
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.
Exclusion Criteria (Patients):
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan C Moss, MD PhD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
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