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

This study is currently recruiting participants.
Verified November 2017 by Alan C. Moss, Beth Israel Deaconess Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02417974
First Posted: April 16, 2015
Last Update Posted: November 16, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Brigham and Women's Hospital
Boston Medical Center
Massachusetts Institute of Technology
Information provided by (Responsible Party):
Alan C. Moss, Beth Israel Deaconess Medical Center
  Purpose
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.

Condition Intervention Phase
Crohn's Disease Biological: Fecal Microbiota Transplant (FMT) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)

Resource links provided by NLM:


Further study details as provided by Alan C. Moss, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 44
Study Start Date: September 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fecal Microbiota Transplant (FMT)
Fecal Microbiota Transplant (FMT) via colonoscopy
Biological: Fecal Microbiota Transplant (FMT)
Fecal Microbiota Transplant (FMT)
Other Names:
  • Fecal Transplant
  • Stool Transplant
No Intervention: Control
No Fecal Microbiota Transplant (FMT) via colonoscopy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02417974


Contacts
Contact: Amanda Ting 617-667-0558 ajting@caregroup.org

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Amanda Ting    617-667-0558    ajting@caregroup.org   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Boston Medical Center
Massachusetts Institute of Technology
Investigators
Principal Investigator: Alan C Moss, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Alan C. Moss, MD, IBD Specialist, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02417974     History of Changes
Other Study ID Numbers: 2015P000100
First Submitted: April 1, 2015
First Posted: April 16, 2015
Last Update Posted: November 16, 2017
Last Verified: November 2017

Keywords provided by Alan C. Moss, Beth Israel Deaconess Medical Center:
Prevention
Recurrence
Fecal Microbiota Therapy

Additional relevant MeSH terms:
Crohn Disease
Recurrence
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes