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Clinical Trials/NCT03106844
NCT03106844CompletedPhase 1

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

Brigham and Women's Hospital1 site in 1 country50 target enrollmentStarted: August 1, 2017Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Number of Participants With FMT Failure
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Treatment

Experimental

All patients in this study will receive Fecal Microbiota Tranplantation

Intervention: Fecal Microbiota Transplantation (Drug)

Outcomes

Primary Outcomes

Number of Participants With FMT Failure

Time Frame: 8 weeks

Recurrence of c.diffile infection

Secondary Outcomes

  • Participants Colonized With C.Difficile(8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jessica Ravikoff Allegretti

Principle Investigator

Brigham and Women's Hospital

Study Sites (1)

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