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

Boston Medical Center (BMC)

Status and phase: Terminated; Phase 2

Conditions: Crohn's Disease

Treatments: Biological: Fecal Microbiota Transplant (FMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT02417974

H-34244

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Fecal Microbiota Transplant (FMT)

Experimental group

Description:

Fecal Microbiota Transplant (FMT) via colonoscopy

Treatment:

Biological: Fecal Microbiota Transplant (FMT)

Control

No Intervention group

Description:

No Fecal Microbiota Transplant (FMT) via colonoscopy