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

Inflammatory Bowel Diseases Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03829475
• Other study ID #: 2018
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 1, 2020
• Est. completion date: March 1, 2024

Study information

• Verified date: January 2024
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: March 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections
• Infections
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Drug:
• Bezlotoxumab
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).
• Placebo
placebo is an infusion of normal saline.
• Fecal Microbiota Transplantation
FMT is an infusion of prescreened donor stool that will be administered via colonoscopy

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clostridium difficile recurrence	positive test for CDI by EIA toxin	8 weeks
Primary	Clostridium difficile recurrence	Diarrhea defined at 3 or more bowel movements bristol 6-7 for 2 consecutive days	8 weeks
Secondary	Diarrheal symptoms	Number of Bowel movements daily	12 weeks
Secondary	Rectal bleeding	presence or absence of rectal bleeding	12 weeks
Secondary	Abdominal Pain	presence of absence of abominal pain	12 weeks