Phase 2
N=50
The ICON Study: Outcomes After FMT for Patients With IBD and CDI
Inflammatory Bowel Diseases · Clostridium Difficile Infection
Bottom Line
View on ClinicalTrials.gov: NCT03106844 ↗Enrolled (actual)
50
Serious AEs
6.0%
Results posted
Sep 2020
Primary outcome: Primary: Number of Participants With FMT Failure — 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fecal Microbiota Transplantation (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With FMT Failure |
4 | — |
| SECONDARY Participants Colonized With C.Difficile |
5 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT03106844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.