ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI

Phase 2

Active, not recruiting

• Conditions: Inflammatory Bowel Diseases; Clostridium Difficile Infection
• Interventions: Drug: Bezlotoxumab; Drug: Placebo; Drug: Fecal Microbiota Transplantation

• Registration Number: NCT03829475
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-26
• Study First Submitted QC: 2019-02-01
• Study First Posted: 2019-02-04
• Study Start: 2020-01-01
• Primary Completion: 2023-08-03
• Results First Submitted: 2024-08-17
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Results First Posted: 2024-12-11
• Last Update Posted: 2024-12-11
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 61

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FMT + Bezlo	Bezlotoxumab	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.
FMT + Bezlo	Fecal Microbiota Transplantation	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.
FMT + Placebo	Placebo	Patients in this arm will receive a single FMT via colonoscopy (250ml) and a placebo (saline) infusion (250cc) over
FMT + Placebo	Fecal Microbiota Transplantation	Patients in this arm will receive a single FMT via colonoscopy (250ml) and a placebo (saline) infusion (250cc) over

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clostridium Difficile Recurrence	8 weeks	positive test for CDI by EIA toxin

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States