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

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ClinicalTrials.gov Identifier: NCT03829475
Recruitment Status : Not yet recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Jessica Ravikoff Allegretti, 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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Clostridium Difficile Infection Drug: Bezlotoxumab Drug: Placebo Drug: Fecal Microbiota Transplantation Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: FMT + Bezlo
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
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).
Other Name: Zinplava

Drug: Fecal Microbiota Transplantation
FMT is an infusion of prescreened donor stool that will be administered via colonoscopy
Other Name: FMT

Placebo Comparator: FMT + Placebo
Patients in this arm will receive a single FMT via colonoscopy (250ml) and a placebo (saline) infusion (250cc) over
Drug: Placebo
placebo is an infusion of normal saline.
Other Name: Saline

Drug: Fecal Microbiota Transplantation
FMT is an infusion of prescreened donor stool that will be administered via colonoscopy
Other Name: FMT




Primary Outcome Measures :
  1. Clostridium difficile recurrence [ Time Frame: 8 weeks ]
    positive test for CDI by EIA toxin

  2. Clostridium difficile recurrence [ Time Frame: 8 weeks ]
    Diarrhea defined at 3 or more bowel movements bristol 6-7 for 2 consecutive days


Secondary Outcome Measures :
  1. Diarrheal symptoms [ Time Frame: 12 weeks ]
    Number of Bowel movements daily

  2. Rectal bleeding [ Time Frame: 12 weeks ]
    presence or absence of rectal bleeding

  3. Abdominal Pain [ Time Frame: 12 weeks ]
    presence of absence of abominal pain



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829475


Contacts
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Contact: Jonathan Hurtado 6177329223 jhurtado@bwh.harvard.edu
Contact: Jessica Allegretti 6177326389 jallegretti@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital

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Responsible Party: Jessica Ravikoff Allegretti, Director, Fecal Microbiota Transplantation Program, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03829475     History of Changes
Other Study ID Numbers: 2018
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jessica Ravikoff Allegretti, Brigham and Women's Hospital:
Crohn's DIsease
Ulcerative Colitis

Additional relevant MeSH terms:
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Infection
Intestinal Diseases
Inflammatory Bowel Diseases
Clostridium Infections
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Gram-Positive Bacterial Infections
Bacterial Infections
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs