EGESTA - Emergent GI Therapy for Severe, Complicated CDI Using Fecal Microbiota Transplant (EGESTA)

Inclusion Criteria:

• Adults between 18 years of age and 75 years of age.
• Have CDI defined as clinical symptoms of CDI (diarrhea with or without abdominal pain/abdominal distention) with a confirmatory nucleic acid amplification test (NAAT) positive for CDI.

• Have severe/complicated disease as defined by ACG guidelines(appendix 1), with any of the following attributable to CDI:

  • Admission to intensive care unit for CDI
  • Hypotension (systolic blood pressure < 90 mmHg) with or without required use of vasopressors
  • Fever ≥ 38.5 ° C
  • Ileus (as defined by the absence of intestinal function for at least 24 hours and/or radiographic evidence of pathologically dilated small intestine without evidence of a mechanical obstruction) or significant abdominal distention
  • Mental status changes
  • WBC ≥ 35,000 cells / mm 3 or < 2,000 cells / mm 3
  • Serum lactate levels >2.2 mmol / l
  • End organ failure (mechanical ventilation,renal failure as defined by a rise in creatinine of >1.5 mg/dL either above the upper limit of normal for creatinine, or > 1.5 mg/dL from premorbid levels if that information is known, acute hepatic dysfunction as defined by an increase in AST or ALT to twice the upper limit of normal, etc.)

Exclusion Criteria:

• Pregnant or lactating women
• Prisoners
• Patients under the age of 18 or over the age of 76 years of age

• Patients who are immunocompromised including but not limited to:

  • Have HIV infection historically reported, regardless of CD4 count
  • AIDS as defined by either an AIDS-defining diagnosis (appendix 2) or a CD4 count <200/mm3,
  • Inherited or primary immune disorders,
  • Received chemotherapy within the previous 90 days, or
  • Current or recent treatment with any immunosuppressant medications in the past 90 days
• Individuals who have received FMT at any time before potential study enrollment
• Patients who do not have a stool test confirming C. difficile infection
• Patients who have a severe anaphylactic response to food
• Patients with allergies to sodium chloride or glycerol, both ingredients Generally Recognized As Safe (GRAS)
• Patients who have colorectal cancer
• Diagnosis of Irritable Bowel Disease or Irritable Bowel Syndrome
• Any other condition for which the Principal Investigator thinks the treatment may pose a health risk
• Anticipated or predicted death within the time period of follow-up for reasons unrelated to CDI
• An APACHE II score >29 at the time of evaluation for inclusion in the study protocol (Appendix 4.0)
• Mandatory ongoing antibiotic use for non-CDI infection
• Patients unable to provide informed consent or who do not have a legally authorized representative for consent
• Patients unable to comply with requirements of this study protocol