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The ICON Study: Outcomes After FMT for Patients With IBD and CDI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03106844
Recruitment Status : Recruiting
First Posted : April 10, 2017
Last Update Posted : October 7, 2019
Indiana University
Icahn School of Medicine at Mount Sinai
The Miriam Hospital
Information provided by (Responsible Party):
Jessica Ravikoff Allegretti, Brigham and Women's Hospital

Brief Summary:
In this study the investigators will evaluate patients with IBD and and at least 2 confirmed c.difficile infections who will be undergoing FMT. The investigators will assess patients before FMT and then follow patients prospectively post FMT at week 1, 8 and 12 to assess for recurrence of c.difficile infection and IBD outcomes.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Clostridium Difficile Infection Drug: Fecal Microbiota Transplantation Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The ICON Study: Inflammatory Bowel Disease and Recurrent Clostridium Difficile Infection: Outcomes After Fecal Microbiota Transplantation
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Treatment
All patients in this study will receive Fecal Microbiota Tranplantation
Drug: Fecal Microbiota Transplantation
Patients with at least 2 episodes of CDI and IBD will undergo a single FMT
Other Name: FMT

Primary Outcome Measures :
  1. FMT Failure [ Time Frame: 8 weeks ]
    Recurrence of c.diffile infection

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Adults age 18 or greater
  • Confirmed recurrent CDI by positive PCR or EIA toxin test defined at ≥ 2 episodes and vancomycin failure within one year with the most recent being within the past 3 months.
  • Confirmed diagnosis of IBD with colonic involvement (ulcerative colitis, Crohn's colitis or ileocolitis or indeterminate colitis) for ≥ 3 months
  • Undergoing FMT via colonoscopy for CDI as part of standard medical care

Exclusion Criteria:

  • Unable or unwilling to undergo a colonoscopy
  • Inpatient status
  • Anticipated immediate or upcoming surgery within 30 days
  • Need for continued non-anti-CDI antibiotic therapy
  • History of total or subtotal proctocolectomy
  • Isolated ileal or small bowel disease
  • Pregnancy or lactation
  • 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
  • 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
  • Known concurrent HIV, Hepatitis B or C infection
  • Concurrent PSC
  • Patients with WBC< 3.0 x109th/L at baseline
  • Patients with platelet count < 100 x109th/L
  • Patients with initial elevation of AST or ALT > 1.5 times above normal limit at baseline
  • Non - steroidal anti-inflammatory medications (NSAIDs) as long-term treatment, defined as use for at least 4 days a week each month
  • Treatment with vancomycin or metronidazole for more then 60 days prior to enrollment

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 identifier (NCT number): NCT03106844

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Contact: Jessica R Allegretti, MD,MPH 617-732-6389
Contact: Madeline Carrellas

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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jessica Allegretti, MD, MPH    617-732-6389   
Contact: Jonathan Hurtado    617-732-9223   
Sponsors and Collaborators
Brigham and Women's Hospital
Indiana University
Icahn School of Medicine at Mount Sinai
The Miriam Hospital
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Principal Investigator: Jessica R Allegretti, MD, MPH Brigham and Women's Hospital
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Responsible Party: Jessica Ravikoff Allegretti, Principle Investigator, Brigham and Women's Hospital Identifier: NCT03106844    
Other Study ID Numbers: 2017P000386
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Additional relevant MeSH terms:
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Clostridium Infections
Enterocolitis, Pseudomembranous
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gram-Positive Bacterial Infections
Bacterial Infections