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

NCT ID: NCT02417974

Last Updated: 2022-03-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2021-02-04

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Fecal Microbiota Transplant (FMT)

Fecal Microbiota Transplant (FMT) via colonoscopy

Group Type: EXPERIMENTAL

Fecal Microbiota Transplant (FMT)

Intervention Type: BIOLOGICAL

Fecal Microbiota Transplant (FMT)

Control

No Fecal Microbiota Transplant (FMT) via colonoscopy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fecal Microbiota Transplant (FMT)

Fecal Microbiota Transplant (FMT)

Intervention Type: BIOLOGICAL

Other Intervention Names

Fecal Transplant; Stool Transplant

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Massachusetts Institute of Technology

OTHER

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alan C Moss, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H-34244

Identifier Type: -

Identifier Source: org_study_id