Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/18/2017 |
| Start Date: | September 2015 |
| End Date: | December 2018 |
| Contact: | Amanda Ting |
| Email: | ajting@caregroup.org |
| Phone: | 617-667-0558 |
The objective of this trial is to assess if Fecal Microbiota Therapy (FMT) can reduce the
risk of endoscopic recurrence of 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.
risk of endoscopic recurrence of 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.
Inclusion Criteria (Patients):
- Adults (age > 18)
- Confirmed diagnosis of Crohn's disease, 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-TNFs, 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
We found this trial at
1
site
330 Brookline Ave
Boston, Massachusetts 02215
Boston, Massachusetts 02215
617-667-7000
Phone: 617-667-0558
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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