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Phase 1
18 Years
Open (Enrolling)
Crohn's Disease

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Trial Information

Inclusion Criteria

Inclusion Criteria (Patients):

- CD confirmed by biopsy for > 3 months duration

- Active disease (Harvey-Bradshaw Index > 8

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Safety of FMT in patients with Crohn's disease, as measured by number and nature of adverse events

Outcome Time Frame:

24 weeks

Safety Issue:


Principal Investigator

Alan C Moss, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2013

Completion Date:

April 2014

Related Keywords:

  • Crohn's Disease
  • Crohn Disease
  • Inflammatory Bowel Diseases



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215