Status:
COMPLETED
ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Inflammatory Bowel Diseases
Clostridium Difficile Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a randomized controlled trial to assess the clinical and microbiological impacts of FMT in combination with Bezlotoxumab (bezlo) compared to FMT in combination with placebo in patients with bo...
Eligibility Criteria
Inclusion
- Adults age 18 or greater
- History of ≥ 2 episodes of recurrent CDI. CDI is defined as the presence of diarrhea ( Bristol 6 or 7 for 48 hours and a confirmatory test for CDI). Preferred testing will be a two-step method using GDH/EIA toxin, though PCR will be accepted based on hospital availability with confirmation of the most recent episode occurring within the prior 3 months
- Confirmed diagnosis of IBD (ulcerative colitis, Crohn's disease or indeterminate colitis)
- Undergoing FMT via colonoscopy for CDI as part of standard medical care
Exclusion
- Unable or unwilling to undergo a colonoscopy
- Inpatient status, though patients can be screened while inpatients, the must be outpatient for the planned colonoscopy.
- Anticipated immediate or upcoming surgery within 30 days
- Need for continued non-anti-CDI antibiotic therapy
- History of total proctocolectomy
- Female patients who are pregnant or breastfeeding or plan to become pregnant in the next 6 months.
- Patients who are unable to give informed consent
- Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
- Severe food allergy (anaphylaxis or anaphylactoid-like reaction)
- Life expectancy \< 6 months
- Unable to adhere to protocol requirements
- Patient who have received an FMT in the past year
- Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines that it will put the subject at greater risk from FMT
- Patient who is diagnosed with NYHA class 3 or 4 Heart Failure
- Lab value of WBC \<3.0 x 103/mm3 , Platelets \<100 x 103/mm3 , ALT or AST \> 1.5 x institutional ULN
- EBV or CMV negative if a patient is severely immunosuppressed ( defined as 3 or more immunosuppressing agents)
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT03829475
Start Date
January 1 2020
End Date
June 1 2025
Last Update
December 9 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115