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Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT) (FMT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02417974
Recruitment Status : Suspended (Currently suspended due to COVID-19 policies.)
First Posted : April 16, 2015
Last Update Posted : April 7, 2020
Sponsor:
Collaborators:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts Institute of Technology
Information provided by (Responsible Party):
Boston Medical Center

Tracking Information
First Submitted Date  ICMJE April 1, 2015
First Posted Date  ICMJE April 16, 2015
Last Update Posted Date April 7, 2020
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2015)
Post-operative endoscopic recurrence [ Time Frame: within 6 months of ileo-cecal resection ]
Proportion 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 or equal to i2
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2015)
  • Microbial Diversity: reference sequence operational taxonomic units (OTUs) [ Time Frame: 2, 4, 8, 10, 12, 16, 20, and 26 weeks ]
    Recipients' fecal microbial diversity at 2, 4, 8, 10, 12, 16, 20, and 26 weeks after FMT, when compared to baseline
  • Inflammatory Endpoint: Rutgeert's score [ Time Frame: 26 weeks ]
    Percentage of patients with normal anastamosis (Rutgeert's score 0) at 26 weeks
  • Inflammatory: Mean CRP [ Time Frame: 26 weeks ]
    Each patient's mean CRP calculated at 26 weeks
  • Clinical HBI [ Time Frame: 26 weeks ]
    Mean Harvey Bradshaw Index (HBI) score at week 26 and percentage of patients in clinical remission (those with an HBI score at week 26 that is less than 5)
  • Adverse Events frequency [ Time Frame: 4, 12, and 26 weeks ]
    Number and nature of adverse events at 4, 12, and 26 weeks for each patient
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
Official Title  ICMJE Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
Brief Summary The objective of this trial is to assess if Fecal Microbiota Therapy (FMT) can reduce the risk of endoscopic recurrence of 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Crohn's Disease
Intervention  ICMJE Biological: Fecal Microbiota Transplant (FMT)
Fecal Microbiota Transplant (FMT)
Other Names:
  • Fecal Transplant
  • Stool Transplant
Study Arms  ICMJE
  • Experimental: Fecal Microbiota Transplant (FMT)
    Fecal Microbiota Transplant (FMT) via colonoscopy
    Intervention: Biological: Fecal Microbiota Transplant (FMT)
  • No Intervention: Control
    No Fecal Microbiota Transplant (FMT) via colonoscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: April 13, 2015)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria (Patients):

  • Adults (age > 18)
  • Confirmed diagnosis of Crohn's disease, 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-TNFs, 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02417974
Other Study ID Numbers  ICMJE H-34244
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boston Medical Center
Study Sponsor  ICMJE Boston Medical Center
Collaborators  ICMJE
  • Brigham and Women's Hospital
  • Beth Israel Deaconess Medical Center
  • Massachusetts Institute of Technology
Investigators  ICMJE
Principal Investigator: Alan C Moss, MD PhD Boston Medical Center
PRS Account Boston Medical Center
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP