NCT03829475CompletedPhase 2
ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI
A Randomized Controlled Trial to Compare the Effectiveness of Fecal Microbiota Transplantation (FMT) in Combination With Bezlotoxumab Compared to FMT and Placebo for the Prevention of CDI Recurrence in Patients With Inflammatory Bowel Disease and Recurrent Clostridium Difficile Infection
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
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 both inflammatory bowel disease (IBD) a and clostridium difficile infection (CDI). The investigators will prospectively enroll up to 150 IBD-CDI patients from 4 tertiary care FMT referral centers. Patients will be randomized 1:1 to either receive FMT in combination with Bezlo of FMT and a placebo infusion. Donor stool from healthy donors will be obtained from OpenBiome. OpenBiome is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use. Patients will be enrolled and followed prospectively for 3 months post therapy. Stool and blood samples as well as clinical data will be collected at baseline, week 1, 8 and 12.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 61 (actual)
- First submitted
- 26 Jan 2019
- Start date
- 1 Jan 2020
- Primary completion date
- 3 Aug 2023
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT03829475
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 61
- From 1 Jan 2020 to the primary completion date, 3 Aug 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Anticipated immediate or upcoming surgery within 30 days
- Need for continued non-anti-CDI antibiotic therapy
- Patient who have received an FMT in the past year
Other illness
- History of total proctocolectomy
- Severe food allergy (anaphylaxis or anaphylactoid-like reaction)
- 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 values
- Lab value of WBC \<3.0 x 103/mm3 , Platelets \<100 x 103/mm3 , ALT or AST \> 1.5 x institutional ULN
Other
- Unable or unwilling to undergo a colonoscopy
- Inpatient status, though patients can be screened while inpatients, the must be outpatient for the planned colonoscopy.
- 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
- Life expectancy \< 6 months
- Unable to adhere to protocol requirements
- EBV or CMV negative if a patient is severely immunosuppressed ( defined as 3 or more immunosuppressing agents)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.