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Trial record 1 of 1 for:    NCT02417974
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Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT) (FMT)

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ClinicalTrials.gov Identifier: NCT02417974
Recruitment Status : Terminated (Low enrollment was exacerbated by a covid policy related study suspension so the research was stopped.)
First Posted : April 16, 2015
Results First Posted : March 24, 2022
Last Update Posted : March 24, 2022
Sponsor:
Collaborators:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts Institute of Technology
Information provided by (Responsible Party):
Boston Medical Center

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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)
Actual Study Start Date : September 2015
Actual Primary Completion Date : February 4, 2021
Actual Study Completion Date : February 4, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in Microbial Diversity: Shannon Diversity Index [ Time Frame: baseline, 4, 12, and 26 weeks ]
    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.

  2. Number of Participants in Clinical Remission at 26 Weeks [ Time Frame: 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.

  3. Adverse Events Frequency [ Time Frame: 4, 12, and 26 weeks ]
    Number of participants with adverse events


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


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Boston Medical Center
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts Institute of Technology
Investigators
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Principal Investigator: Alan C Moss, MD PhD Boston Medical Center
  Study Documents (Full-Text)

Documents provided by Boston Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] November 10, 2017

More Information
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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT02417974    
Other Study ID Numbers: H-34244
First Posted: April 16, 2015    Key Record Dates
Results First Posted: March 24, 2022
Last Update Posted: March 24, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Medical Center:
Prevention
Recurrence
Fecal Microbiota Therapy
Additional relevant MeSH terms:
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Crohn Disease
Recurrence
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes