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COMPLETEDPHASE1/PHASE2

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

NCT03106844•Brigham and Women's Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+11 more criteria

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

August 1, 2017

Primary Completion Date

April 7, 2020

Completion Date

December 31, 2020

Last Updated

February 10, 2021

Enrollment

ACTUAL participants

Conditions

Inflammatory Bowel DiseasesClostridium Difficile Infection

Interventions

Fecal Microbiota Transplantation

DRUG

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

NCT06237452

Clostridium DifficileClostridium Difficile Infections+8 more

View study

RECRUITINGPHASE2

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

Institutional Registry of Rare Diseases

Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study

Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance

Clinnova-IBD, a Prospective Cohort of Patients With Inflammatory Bowel Disease (IBD)