Inflammatory Bowel Diseases Clinical Trial
Official title:
The ICON Study: Inflammatory Bowel Disease and Recurrent Clostridium Difficile Infection: Outcomes After Fecal Microbiota Transplantation
Verified date | October 2020 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Icahn School of Medicine at Mount Sinai, Indiana University, The Miriam Hospital |
United States,
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 |
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