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

Description

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 Start Date

August, 01 2017

Estimated Completion Date

December 2018

Interventions

  • Drug: Fecal Microbiota Transplantation

Study ID

Brigham and Women's Hospital -- 2017P000386

Status

Recruiting

Trial ID

NCT03106844

Study Type

Interventional

Trial Phase

Phase 1/Phase 2

Enrollment Quota

50

Sponsor

Brigham and Women's Hospital

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

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (5)

Study Location Distance Name Phone Email
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Jessica Allegretti MD MPH 617-732-6389 jallegretti@partners.org
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Jessica Allegretti MD MPH 617-732-6389 jallegretti@partners.org
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Jessica Allegretti MD MPH 617-732-6389 jallegretti@partners.org
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Jessica Allegretti MD MPH 617-732-6389 jallegretti@partners.org
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Jessica Allegretti MD MPH 617-732-6389 jallegretti@partners.org

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