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

NCT03106844 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-02-10

Study results available
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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.

Conditions

  • Inflammatory Bowel Diseases
  • Clostridium Difficile Infection

Interventions

DRUG

Fecal Microbiota Transplantation

Patients with at least 2 episodes of CDI and IBD will undergo a single FMT

Sponsors & Collaborators

Principal Investigators

  • Jessica R Allegretti, MD, MPH · Brigham and Women's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2020-04-07
Completion
2020-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03106844 on ClinicalTrials.gov