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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03106844
• Other study ID #: 2017P000386
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2020
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: April 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections
• Enterocolitis, Pseudomembranous
• Infection
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Drug:
• Fecal Microbiota Transplantation
Patients with at least 2 episodes of CDI and IBD will undergo a single FMT

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Icahn School of Medicine at Mount Sinai, Indiana University, The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With FMT Failure	Recurrence of c.diffile infection	8 weeks
Secondary	Participants Colonized With C.Difficile	asymptomatic patients with positive stool testing for c.difficile via polymerase chain reaction testing	8 weeks