Back to Crohns Disease And Colitis
NCT01847170
NCT01847170
Who may be able to join
Who might be able to join this trial:
- You have been diagnosed with Crohn's disease, confirmed by a tissue biopsy, for more than 3 months
- Your Crohn's disease is currently active, based on a specific symptom score used by doctors (confirm with trial site)
- You have tried standard treatments that have not worked well enough, such as certain anti-inflammatory medications, immune-suppressing drugs, or you are currently dependent on steroids at a low dose and unable to stop taking them
- Your current medications have been at a stable dose for at least 2 weeks
- You are 18 years of age or older
Who may not be able to join:
- You have been diagnosed with indeterminate colitis or proctitis (inflammation limited only to the rectum)
- You have severe or rapidly worsening colitis
- You are pregnant or currently breastfeeding
- You are unable to give your own informed consent to participate
- You are unable or unwilling to have a colonoscopy procedure with sedation
- You have previously had a fecal microbiota transplant (a procedure involving stool from a donor)
- You have been diagnosed with any form of cancer or malignancy
- Your immune system is weakened for any reason
- You have taken certain specific medications (including cyclosporine, tacrolimus, infliximab, adalimumab, certolizumab, natalizumab, thalidomide) within the last 12 weeks
- You have taken antibiotics within the last 2 months
- You have taken part in another clinical trial in the last 30 days or are currently in another trial
- You have taken probiotic supplements within the last 30 days
- You have used any rectal treatments (such as suppositories or enemas) within the last 14 days
- You have advanced liver disease (decompensated cirrhosis)
- You have an immune deficiency condition, whether inherited or developed
- You have certain other health conditions, including diabetes, lupus, chronic kidney disease (with significantly reduced kidney function), or a history of heart valve disease or endocarditis
- You are currently taking steroids at a dose higher than 20mg per day
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Trial details
Status
Completed
Phase
Phase 1
Sponsor
Beth Israel Deaconess Medical Center
Registry
clinicaltrials_gov
Start date
1 May 2013
Est. completion
1 November 2016
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Safety of FMT in patients with Crohn's disease, as measured by number and nature of adverse events; Recipients' fecal microbial diversity after FMT, when compared to baseline
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.