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

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.

Study Overview

• Status: Terminated
• Conditions: Crohn's Disease
• Intervention / Treatment: Biological: Fecal Microbiota Transplant (FMT)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: Stool Transplant; Fecal Transplant
No Intervention: Control; No Fecal Microbiota Transplant (FMT) via colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, 4, 12, and 26 weeks
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.	26 weeks
Adverse Events Frequency	Number of participants with adverse events	4, 12, and 26 weeks

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Massachusetts Institute of Technology
• Investigators: Principal Investigator: Alan C Moss, MD PhD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): February 4, 2021
• Study Completion (Actual): February 4, 2021

Study Registration Dates

• First Submitted: April 1, 2015
• First Submitted That Met QC Criteria: April 13, 2015
• First Posted (Estimate): April 16, 2015

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: February 26, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Recurrence; Prevention; Fecal Microbiota Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Recurrence; Crohn Disease
• Other Study ID Numbers: H-34244

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No