ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Infectious Disease, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/6/2019 |
| Start Date: | March 1, 2019 |
| End Date: | December 30, 2021 |
| Contact: | Jonathan Hurtado |
| Email: | jhurtado@bwh.harvard.edu |
| Phone: | 6177329223 |
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
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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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)
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