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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
24
Fecal Microbiota Transplant (FMT)
Boston Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
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
Time frame: within 6 months of ileo-cecal resection
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.
Time frame: 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.
Time frame: 26 weeks
Adverse Events Frequency
Number of participants with adverse events
Time frame: 4, 12, and 26 weeks
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