Status:
COMPLETED
Impact of Fecal Biotherapy (FBT) on Microbial Diversity in Patients With Moderate to Severe Inflammatory Bowel Disease
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
The Broad Foundation
Brigham and Women's Hospital
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The human immune system is usually tolerant of the millions of beneficial commensal bacteria (the microbiome), which colonize the healthy intestinal tract. In contrast, patients with Inflammatory Bowe...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Patients):
- CD confirmed by biopsy for \> 3 months duration
- Active disease (Harvey-Bradshaw Index \> 5
- Failed standard therapy with; stable doses of 5-ASA \>2 weeks; thiopurines \>3 months; or is steroid dependent at a dose \<20mg/d; (inability to taper off steroid for longer than 1 week)
- Stable medication regimen for \>2 weeks.
- Age \> 18 years old
- Exclusion Criteria (Patients):
- Diagnosis of indeterminate colitis, or proctitis alone
- Severe or fulminate 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
- Patients who are immunocompromised
- Treatment within last 12 weeks with cyclosporine, tacrolimus, infliximab, adalimumab, certolizumab, natalizumab, thalidomide
- Antibiotic use within 2-months of start date
- Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
- Probiotic use within 30 days of start date
- Rectal therapy within 14 days of start date
- Decompensated cirrhosis
- Congenital or acquired immunodeficiencies
- Other comorbidities including:
- Diabetes mellitus, cancer, systemic lupus, must be able to tolerate conscious sedation with colonoscopy
- 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
- Steroid dose \>20mg/day
Exclusion
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01847170
Start Date
May 1 2013
End Date
November 1 2016
Last Update
March 3 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215