Fecal microbiota transplant for recurrent clostridium difficile infection

HS 2013-9455
Digestive Disease, Colitis, Inflammatory Bowel Disease, Ulcerative colitis, Crohn’s disease
Nimisha K. Parekh, MD

UC Irvine Medical Center

This is a single cohort observational study to investigate specific, quantifiable outcomes of patients with refractory Clostridium difficile infection undergoing fecal microbiota transplant (FMT).

Primary Aim

  • To examine the recurrence rate of Clostridium difficile four weeks after FMT 
Secondary Aims
  • To evaluate the change of clinical symptoms from before FMT to four weeks after FMT
  • To assess satisfaction with the FMT procedure
  • To evaluate quality of life before FMT and four weeks after FMT
  • To track alternate treatments needed for Clostridium difficile before and after FMT
  • To evaluate the rate of adverse events that may be related to FMT

Hypothesis
Clostridium difficile infection will recur in 20 percent to 30 percent of cases, usually within 30 days of the treatment period. We hypothesize that after treatment with FMT, the recurrence rate of Clostridium difficile at four weeks will be reduced, possibly to 15 percent.


Inclusion criteria

Participant (recipient) — eligible patient must meet all of the following criteria:

  • Be between the age of 18 and 100
  • Have Clostridium difficile infection (defined as > 3 loose stools a day and Clostridium difficile positive PCR or toxin test)
  • Have failed at least one standard course of antibiotic therapy, defined as one of the below:
    • Metronidazole 500 mg three times a day for 10 to 14 days 
    • Vancomycin 125 mg four times a day for 10 to 14 days
  • Not be pregnant and have negative urine and/or serum HCG test
  • Not be taking oral or IV steroids in the past three months. 
  • Not on biologic agents, anti-TNF agents, cyclosporine, mercaptopurine, azathioprine, methotrexate or chemotherapy in the preceding three months
  • Not have profound immunosuppression, chemotherapy in the preceding three months, HIV/AIDS, decompensated cirrhosis
  • Not be in an intensive care unit
  • Not be a transplant recipient
Donors
  • Be between 18 and 100 years of age
Exclusion criteria 

Participant (recipient) cannot:
  • Be a pregnant woman
  • Be under 18 years of age
  • Have absolute contraindications to receiving enemas or undergoing colonoscopies 
  • Have anaphylactic reaction to nuts or other food substances (as this cannot be controlled for with 100 percent certainty in the donor stool)
  • Be in the ICU
  • Be significantly immunocompromised, chemotherapy in the preceding three months, HIV/AIDS, transplant recipient, liver cirrhosis
  • Have received oral or IV steroids in the preceding three months
  • Have used biologic agents, antiTNF agents, cyclosporine, mercaptopurine, azathioprine, methotrexate or chemotherapy in the preceding three months 
Donors cannot
  • Be positive for transmissible disease on screening blood and stool tests
  • Have had antibiotics within the preceding three months
  • Have active gastroesophageal reflux disease (GERD) requiring proton pump inhibitor (PPI) therapy, or use of any PPIs (as PPI use is known to increase the risk of Clostridium difficile infection)
  • Have a recent incarceration
  • Have high-risk sexual behavior that would cause potential exposure to transmissible diseases (examples of high-risk sexual behavior include exchange of sex for money, having multiple sex partners, unprotected intercourse without condom use except in long-term, monogamous relationship).
  • Have recent tattoos or piercings within the preceding three months
  • Be in an immunocompromised state
  • Have received recent anti-neoplastic agents within the preceding three months (i.e., chemotherapy)
  • Have a history of gastrointestinal disorders, including bowel dysmotility — either diarrhea, constipation, irritable bowel syndrome, neoplasia, inflammatory bowel disease
  • Have a history of autoimmune disorders, atopic illnesses, morbid obesity, metabolic syndrome or chronic fatigue syndrome due to theoretical risk of these diseases being driven by microbiome dysbiosis.¹
  • Have been hospitalized within the last three months
  • Have any significant concurrent medical, social or psychological illness which, in the opinion of the investigators, would interfere with their eligibility for the study (examples include homelessness, paranoid schizophrenia, autoimmune conditions).

Approximately five hours

The potential benefit to recipient subjects includes:
  • Cure of Clostridium difficile infection.
  • Significant improvement in symptoms and quality of life in patients.
  • Decreased need for multiple other pharmaceutical therapies or decreased dosage of such therapy.
There is no direct benefit anticipated for the donor subjects.

None

Yuna Muyshondt, MPH
714-456-2215