The investigators wish to compare Fecal Microbiota Transplant (FMT) capsules to placebo
capsules in subjects with TWO episodes of C. difficile. The investigators have numerous
subjects and physicians requesting FMT at the time of a second relapse, in order to prevent
further hospitalizations, obtain a faster and more durable cure, avoid costly medications
like fidaxomicin and oral vancomycin, and "fix" the underlying dysbiosis. In some instances,
subjects feel like they are being asked to "get sick again" before they can pursue the most
effective option. The investigators propose to study these subjects with a rigorous placebo
controlled design, which will contribute significantly to our understanding of the utility of
FMT, timing, and the real relapse rates in a tertiary referral center. Subjects who relapse
with placebo will by definition have a third episode, meet consensus criteria for FMT, and
will be offered "standard" FMT by capsule at that time. Additionally, this study will allow
us to further capture safety data, in comparison to placebo capsules and further enhance our
understanding of the microbiology of dysbiosis, earlier on in the illness course. Lastly, the
investigators may decide to perform a cost analysis.
- Patients with two episodes of Clostridium dificile infection defined as having
resolved symptoms after an initial microbiologically confirmed diagnosis of C.
difficile, who have completed a course of antibiotics, and have a second positive test
(toxin or PCR) obtained for a relapse of diarrhea symptoms by treating providers.
Subjects with a positive "test of cure" stool sample (NOT advised by SHEA guidelines)
in the absence of relapsed symptoms of CDI, or those who never improved their symptoms
on the initial course of antibiotics will not be eligible. (Subjects who do not have a
response to antibiotics may have other or additional diagnoses which are not likely to
be helped by FMT.)
- Willingness to accept risk of unrelated donor stool.
- Age 18 or above. We do not believe there is a reason to have an upper age limit as
long as patients can consent and can swallow large capsules. The elderly are
disproportionately affected by CDI in terms of incidence, severity and affect on
quality of life given limited mobility.
- Able to consent for self.
- Subjects are not expected to receive additional antibiotics for other indications in
the next 8 weeks.
- Patients on a standard chemotherapeutic regimen for solid tumors, where significant
duration of neutropenia is NOT expected in the 2 weeks following FMT may be enrolled
with the agreement of their oncologist.
- Pt must be willing to have baseline Hepatitis B and C screening, and HIV screening (as
required by the FDA for past studies). Those known to be seropositive for any of these
illnesses need not be retested. These illnesses do not exclude subjects a priori, we
simply wish to document initial sero-status.
- Subjects who have completed a second course of antibiotics may be enrolled up to 7
days after completing their second course of antibiotics for C. difficile
- Delayed gastric emptying syndrome
- Known chronic aspiration
- Swallowing dysfunction or oral-motor dyscoordination, or inability or unwillingness to
swallow multiple large capsules
- Pregnant women; we have previously and will continue to include postpartum and
breastfeeding women. Women of child bearing potential have a urine or serum human
chorionic gonadotropin test at enrollment.
- Patients with an acute illness unrelated to CDI or an acute exacerbation of underlying
- Neutropenia (ANC <500) currently or expected within 2 weeks of FMT. (must have count
within 7 d in relevant subjects, i.e. those with recent chemotherapy)
- Subjects on high dose steroids (>40 mg daily)
- Subjects on multiple/combination immunosuppressive regimens including high dose
corticosteroids, calcineurin inhibitors, lymphocyte depleting biologic agents,
anti-tumor necrosis factor agents. Subjects on a stable dose of a SINGLE
immunosuppressive agent like steroids, rituximab, infliximab, other anti-TNF agents,
with approval of the treating physician may be enrolled. These subjects may be at
greatest risk of complications and hospitalization if another relapse of CDI occurs
and may benefit.
- Patients with decompensated cirrhosis, advanced HIV/AIDS, recent bone marrow
transplant, other cause of severe immunodeficiency.
- Patients with a history of significant allergy to foods not excluded from the donor
diet (excluded foods are tree nuts, peanuts, shellfish, eggs)
- Ongoing systemic antibiotics for other infections (these people are better maintained
on suppressive vancomycin and transplanted later). Subjects may have recently
completed a course of antibiotics for another indication.
- Advanced HIV/AIDS with cluster of differentiation 4 cells (CD4) count less than 50.
- Allergy to chocolate/cocoa or gelatin, or unwillingness to ingest gelatin (in placebo