Clinical trial NCT02417974: Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
Official title: Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Prevention
Recurrence
Fecal Microbiota Therapy
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Beth Israel Deaconess Medical Center
name: Massachusetts Institute of Technology
First posted: 2015-04-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Post-operative Endoscopic Recurrence
timeFrame: within 6 months of ileo-cecal resection
Secondary outcomes:
measure: Change in Microbial Diversity: Shannon Diversity Index
timeFrame: baseline, 4, 12, and 26 weeks
measure: Number of Participants in Clinical Remission at 26 Weeks
timeFrame: 26 weeks
measure: Adverse Events Frequency
timeFrame: 4, 12, and 26 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Alan C Moss, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: