CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Fecal Microbiota Transplantationdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03106844
NCT03106844Phase 2Completed
CompareCT.gov

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

Brigham and Women's Hospital·interventional·Posted Apr 10, 2017·Updated Feb 10, 2021

In Brief

A Phase 2 clinical trial evaluating Fecal Microbiota Transplantation for Inflammatory Bowel Diseases and Clostridium Difficile Infection. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInflammatory Bowel Diseases, Clostridium Difficile Infection
CountriesUnited States
CollaboratorsIndiana University, Icahn School of Medicine at Mount Sinai, The Miriam Hospital

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedApr 10, 2017
Enrollment StartAug 1, 2017
Primary CompletionApr 7, 2020
Study CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.2 years ago

Interventions

Fecal Microbiota Transplantationdrug

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