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

Phase 1

Completed

• Conditions: Inflammatory Bowel Diseases; Clostridium Difficile Infection
• Interventions: Drug: Fecal Microbiota Transplantation

• Registration Number: NCT03106844
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-04
• Study First Posted: 2017-04-10
• Study Start: 2017-08-01
• Primary Completion: 2020-04-07
• Results First Submitted: 2020-08-01
• Results First Submitted QC: 2020-08-31
• Results First Posted: 2020-09-21
• Status Verified: 2020-10
• Study Completion: 2020-12-31
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Fecal Microbiota Transplantation	All patients in this study will receive Fecal Microbiota Tranplantation

Primary Outcome Measures

Name	Time	Method
Number of Participants With FMT Failure	8 weeks	Recurrence of c.diffile infection

Secondary Outcome Measures

Name	Time	Method
Participants Colonized With C.Difficile	8 weeks	asymptomatic patients with positive stool testing for c.difficile via polymerase chain reaction testing

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States