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

The ICON Study: Inflammatory Bowel Disease and Recurrent Clostridium Difficile Infection: Outcomes After Fecal Microbiota Transplantation

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Clostridium Difficile Infection
• Intervention / Treatment: Drug: Fecal Microbiota Transplantation

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: FMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With FMT Failure	Recurrence of c.diffile infection	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants Colonized With C.Difficile	asymptomatic patients with positive stool testing for c.difficile via polymerase chain reaction testing	8 weeks

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Icahn School of Medicine at Mount Sinai; The Miriam Hospital; Indiana University
• Investigators: Principal Investigator: Jessica R Allegretti, MD, MPH, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): April 7, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (Actual): April 10, 2017

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: IBD; FMT
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Inflammatory Bowel Diseases; Intestinal Diseases; Clostridium Infections
• Other Study ID Numbers: 2017P000386

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No