Clostridium Difficile Infection, Inflammatory Bowel Diseases
Conditions
Keywords
FMT, IBD
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.
Interventions
DRUGFecal Microbiota Transplantation
Patients with at least 2 episodes of CDI and IBD will undergo a single FMT
Sponsors
Indiana University
Icahn School of Medicine at Mount Sinai
The Miriam Hospital
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With FMT Failure | 8 weeks | Recurrence of c.diffile infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants Colonized With C.Difficile | 8 weeks | asymptomatic patients with positive stool testing for c.difficile via polymerase chain reaction testing |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment All patients in this study will receive Fecal Microbiota Tranplantation
Fecal Microbiota Transplantation: Patients with at least 2 episodes of CDI and IBD will undergo a single FMT | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 43 years |
| Average Bowel Movements | 5.2 bowel movements STANDARD_DEVIATION 4 |
| Average Bristol Score | 5.6 units on a scale STANDARD_DEVIATION 1.1 |
| Average Complete Mayo | 5.6 units on a scale STANDARD_DEVIATION 3.3 |
| Average Harvey Bradshaw Index | 5.8 units on a scale STANDARD_DEVIATION 3.4 |
| Average Partial Mayo | 4.2 units on a scale STANDARD_DEVIATION 2.1 |
| Baseline Calprotectin | 5.3 mg/L STANDARD_DEVIATION 8.7 |
| Baseline C-Reactive Protein | 1919.6 ug/g STANDARD_DEVIATION 2432.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 47 Participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 49 / 50 |
| serious Total, serious adverse events | 3 / 50 |
Outcome results
Primary
Number of Participants With FMT Failure
Recurrence of c.diffile infection
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants With FMT Failure | 4 Participants |
Secondary
Participants Colonized With C.Difficile
asymptomatic patients with positive stool testing for c.difficile via polymerase chain reaction testing
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Participants Colonized With C.Difficile | 5 Participants |