FMT + Bezlotoxumab for IBD and C. Difficile Infection

(ICON-2 Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Brigham and Women's Hospital

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for adults over 18 with inflammatory bowel disease (IBD) and recurrent Clostridium difficile infection (CDI), who are undergoing fecal microbiota transplantation (FMT) as standard care. Participants must have had at least two CDI episodes, but not received FMT in the past year or be pregnant/breastfeeding. Those with severe allergies, life expectancy under six months, or certain medical conditions are excluded.

Inclusion Criteria

I am receiving a fecal transplant through a colonoscopy for C. diff infection.

I have had Clostridium difficile infection (CDI) at least twice.

I have been diagnosed with IBD (ulcerative colitis, Crohn's disease, or indeterminate colitis).

Exclusion Criteria

I am not infected with EBV or CMV and take 3 or more drugs for immune suppression.

My doctor thinks some conditions or medications I have might make the treatment risky for me.

Doctors think you might not live for more than 6 months.

Treatment Details

Interventions

• Bezlotoxumab (Monoclonal Antibodies)
• Fecal Microbiota Transplantation (Microbiome Modulator)
• Placebo (Other)

Trial Overview The ICON-2 trial tests if adding Bezlotoxumab to FMT is more effective than FMT with a placebo in treating IBD patients with CDI. Up to 150 participants will be randomly assigned to either treatment group and monitored for three months using stool and blood samples along with clinical data.

Participant Groups

Group I: FMT + Bezlo Experimental Treatment 2 Interventions

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.

Group II: FMT + Placebo Placebo Group 2 Interventions

Patients in this arm will receive a single FMT via colonoscopy (250ml) and a placebo (saline) infusion (250cc) over

Fecal Microbiota Transplantation is already approved in Canada for the following indications:

Approved in Canada as Fecal Microbiota Transplantation for:

• Graft-versus-host disease (GVHD)
• Clostridioides difficile infection (CDI)

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Dr. William Curry

Brigham and Women's Hospital

Chief Medical Officer

MD from Columbia University College of Physicians and Surgeons

Dr. Scott Schissel

Brigham and Women's Hospital

Chief Executive Officer since 2021

MD from Columbia University College of Physicians and Surgeons