Back to resultsICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI (ICON-2)
Primary Purpose
Inflammatory Bowel Diseases, Clostridium Difficile Infection
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bezlotoxumab
Placebo
Fecal Microbiota Transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring Crohn's DIsease, Ulcerative Colitis
Eligibility Criteria
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)
Sites / Locations
- Brigham and Women's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
FMT + Bezlo
FMT + Placebo
Arm Description
Patients in this arm will received an FMT via colonoscopy ( 250ml) as well as a single IV infusion of bezlotoxumab (10mg/kg) that will take place over 60 mins.
Patients in this arm will receive a single FMT via colonoscopy (250ml) and a placebo (saline) infusion (250cc) over
Outcomes
Primary Outcome Measures
Clostridium difficile recurrence
positive test for CDI by EIA toxin
Clostridium difficile recurrence
Diarrhea defined at 3 or more bowel movements bristol 6-7 for 2 consecutive days
Secondary Outcome Measures
Diarrheal symptoms
Number of Bowel movements daily
Rectal bleeding
presence or absence of rectal bleeding
Abdominal Pain
presence of absence of abominal pain
Full Information
NCT ID
NCT03829475
First Posted
January 26, 2019
Last Updated
January 5, 2023
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03829475
Brief Title
ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI
Acronym
ICON-2
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Clostridium Difficile Infection
Keywords
Crohn's DIsease, Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FMT + Bezlo
Arm Type
Experimental
Arm Description
Patients in this arm will received an FMT via colonoscopy ( 250ml) as well as a single IV infusion of bezlotoxumab (10mg/kg) that will take place over 60 mins.
Arm Title
FMT + Placebo
Arm Type
Placebo Comparator
Arm Description
Patients in this arm will receive a single FMT via colonoscopy (250ml) and a placebo (saline) infusion (250cc) over
Intervention Type
Drug
Intervention Name(s)
Bezlotoxumab
Other Intervention Name(s)
Zinplava
Intervention Description
This is a a fully human monoclonal antibody that binds to C. difficile toxin B, and is indicated to prevent recurrence of CDI in adults at risk for recurrent CDI (rCDI).
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
placebo is an infusion of normal saline.
Intervention Type
Drug
Intervention Name(s)
Fecal Microbiota Transplantation
Other Intervention Name(s)
FMT
Intervention Description
FMT is an infusion of prescreened donor stool that will be administered via colonoscopy
Primary Outcome Measure Information:
Title
Clostridium difficile recurrence
Description
positive test for CDI by EIA toxin
Time Frame
8 weeks
Title
Clostridium difficile recurrence
Description
Diarrhea defined at 3 or more bowel movements bristol 6-7 for 2 consecutive days
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Diarrheal symptoms
Description
Number of Bowel movements daily
Time Frame
12 weeks
Title
Rectal bleeding
Description
presence or absence of rectal bleeding
Time Frame
12 weeks
Title
Abdominal Pain
Description
presence of absence of abominal pain
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Mitri
Phone
6177329223
Email
Jjmitri@bwh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Allegretti
Phone
6177326389
Email
jallegretti@bwh.harvard.edu
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Allegretti, MD, MPH
Phone
617-732-6389
Email
jallegretti@partners.org
First Name & Middle Initial & Last Name & Degree
Jen Mitri
Phone
617-732-9223
Email
jjmitri@bwh.harvard.edu
12. IPD Sharing Statement
Learn more about this trial
ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI
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