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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03106844
Recruitment Status : Completed
First Posted : April 10, 2017
Results First Posted : September 21, 2020
Last Update Posted : February 10, 2021
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

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : April 7, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arms and Interventions
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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


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


Secondary Outcome Measures :
  1. Participants Colonized With C.Difficile [ Time Frame: 8 weeks ]
    asymptomatic patients with positive stool testing for c.difficile via polymerase chain reaction testing


Eligibility Criteria
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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
Contacts and Locations
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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


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
Indiana University
Icahn School of Medicine at Mount Sinai
The Miriam Hospital
Investigators
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Principal Investigator: Jessica R Allegretti, MD, MPH Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Jessica Ravikoff Allegretti, Brigham and Women's Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] July 7, 2019

More Information
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Responsible Party: Jessica Ravikoff Allegretti, Principle Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03106844    
Other Study ID Numbers: 2017P000386
First Posted: April 10, 2017    Key Record Dates
Results First Posted: September 21, 2020
Last Update Posted: February 10, 2021
Last Verified: October 2020
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:
FMT
IBD
Additional relevant MeSH terms:
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Infections
Clostridium Infections
Enterocolitis, Pseudomembranous
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Gastroenteritis
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Enterocolitis