NCT03106844

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Fecal Microbiota Transplantation	Patients with at least 2 episodes of CDI and IBD will undergo a single FMT

Timeline

• Start date: 2017-08-01
• Primary completion: 2020-04-07
• Completion: 2020-12-31
• First posted: 2017-04-10
• Last updated: 2021-02-10
• Results posted: 2020-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study