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

NCT03829475 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2018
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Clostridium Difficile Infection

Keywords

Crohn's DIsease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clostridium Difficile Recurrence

  positive test for CDI by EIA toxin

  8 weeks

Study Arms (2)

FMT + Bezlo

EXPERIMENTAL

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.

Drug: Bezlotoxumab; Drug: Fecal Microbiota Transplantation

FMT + Placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation DRUG

FMT is an infusion of prescreened donor stool that will be administered via colonoscopy

Also known as: FMT

FMT + Bezlo; FMT + Placebo

Bezlotoxumab DRUG

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).

Also known as: Zinplava

FMT + Bezlo

Placebo DRUG

placebo is an infusion of normal saline.

Also known as: Saline

FMT + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Clostridium Infections; Crohn Disease; Colitis, Ulcerative

Interventions

bezlotoxumab; Sodium Chloride; Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Biological Therapy; Therapeutics

Limitations and Caveats

This study was limited by the sample size as well as the inclusion of PCR only testing for the qualifying episode. .

Results Point of Contact

• Title: Jessica Allegretti MD MPH
• Organization: Brigham and Women's Hospital

jallegretti@bwh.harvard.edu

617-525-7322

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Fecal Microbiota Transplantation Program

Study Record Dates

• First Submitted: January 26, 2019
• First Posted: February 4, 2019
• Study Start: January 1, 2020
• Primary Completion: August 3, 2023
• Study Completion: June 1, 2025
• Last Updated: December 9, 2025
• Results First Posted: December 11, 2024

Record last verified: 2025-11

Locations

US (1)