Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT03106844
Recruitment Status : Recruiting
First Posted : April 10, 2017
Last Update Posted : October 7, 2019
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

Tracking Information
First Submitted Date  ICMJE April 4, 2017
First Posted Date  ICMJE April 10, 2017
Last Update Posted Date October 7, 2019
Actual Study Start Date  ICMJE August 1, 2017
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2017)
FMT Failure [ Time Frame: 8 weeks ]
Recurrence of c.diffile infection
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The ICON Study: Outcomes After FMT for Patients With IBD and CDI
Official Title  ICMJE The ICON Study: Inflammatory Bowel Disease and Recurrent Clostridium Difficile Infection: Outcomes After Fecal Microbiota Transplantation
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Inflammatory Bowel Diseases
  • Clostridium Difficile Infection
Intervention  ICMJE Drug: Fecal Microbiota Transplantation
Patients with at least 2 episodes of CDI and IBD will undergo a single FMT
Other Name: FMT
Study Arms  ICMJE Experimental: Treatment
All patients in this study will receive Fecal Microbiota Tranplantation
Intervention: Drug: Fecal Microbiota Transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 4, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jessica R Allegretti, MD,MPH 617-732-6389 jallegretti@partners.org
Contact: Madeline Carrellas mcarrellas@partners.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03106844
Other Study ID Numbers  ICMJE 2017P000386
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jessica Ravikoff Allegretti, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE
  • Indiana University
  • Icahn School of Medicine at Mount Sinai
  • The Miriam Hospital
Investigators  ICMJE
Principal Investigator: Jessica R Allegretti, MD, MPH Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP