search
Back to results

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

Primary Purpose

Inflammatory Bowel Diseases, Clostridium Difficile Infection

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring FMT, IBD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

All patients in this study will receive Fecal Microbiota Tranplantation

Outcomes

Primary Outcome Measures

Number of Participants With FMT Failure
Recurrence of c.diffile infection

Secondary Outcome Measures

Participants Colonized With C.Difficile
asymptomatic patients with positive stool testing for c.difficile via polymerase chain reaction testing

Full Information

First Posted
April 4, 2017
Last Updated
January 25, 2021
Sponsor
Brigham and Women's Hospital
Collaborators
Indiana University, Icahn School of Medicine at Mount Sinai, The Miriam Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03106844
Brief Title
The ICON Study: Outcomes After FMT for Patients With IBD and CDI
Official Title
The ICON Study: Inflammatory Bowel Disease and Recurrent Clostridium Difficile Infection: Outcomes After Fecal Microbiota Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
April 7, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Indiana University, Icahn School of Medicine at Mount Sinai, The Miriam Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Clostridium Difficile Infection
Keywords
FMT, IBD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
All patients in this study will receive Fecal Microbiota Tranplantation
Intervention Type
Drug
Intervention Name(s)
Fecal Microbiota Transplantation
Other Intervention Name(s)
FMT
Intervention Description
Patients with at least 2 episodes of CDI and IBD will undergo a single FMT
Primary Outcome Measure Information:
Title
Number of Participants With FMT Failure
Description
Recurrence of c.diffile infection
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Participants Colonized With C.Difficile
Description
asymptomatic patients with positive stool testing for c.difficile via polymerase chain reaction testing
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica R Allegretti, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs