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

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ClinicalTrials.gov Identifier: NCT03106844
Recruitment Status : Recruiting
First Posted : April 10, 2017
Last Update Posted : January 18, 2018
Sponsor:
Collaborators:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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 : December 2018
Estimated Study Completion Date : June 2019

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

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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
  • 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 ClinicalTrials.gov identifier (NCT number): NCT03106844


Contacts
Contact: Jessica R Allegretti, MD,MPH 617-732-6389 jallegretti@partners.org
Contact: Madeline Carrellas mcarrellas@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jessica Allegretti, MD, MPH    617-732-6389    jallegretti@partners.org   
Contact: Madeline Carrellas    617-732-9223    mcarrellas@partners.org   
Sponsors and Collaborators
Brigham and Women's Hospital
Indiana University
Icahn School of Medicine at Mount Sinai
The Miriam Hospital
Investigators
Principal Investigator: Jessica R Allegretti, MD, MPH Brigham and Women's Hospital

Responsible Party: Jessica Ravikoff Allegretti, Principle Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03106844     History of Changes
Other Study ID Numbers: 2017P000386
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
FMT
IBD

Additional relevant MeSH terms:
Infection
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis