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

NCT ID: NCT03106844

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2020-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

All patients in this study will receive Fecal Microbiota Tranplantation

Group Type: EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type: DRUG

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

Interventions

Fecal Microbiota Transplantation

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

Intervention Type: DRUG

Other Intervention Names

FMT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

The Miriam Hospital

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jessica Ravikoff Allegretti

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica R Allegretti, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017P000386

Identifier Type: -

Identifier Source: org_study_id