Fecal Microbiota Transplant

Methodist Health System wishes to offer transplant services to our CDI populations which meet all criteria for recurrent intractable disease. The objective is to reduce the cost both financially and physically to patients and the facility, of living with chronic or recurrent CDI disease. This study is to provide treatment and demonstrate documented outcomes and success rates in a manner that protects both the patients and the facility. Of note this treatment is currently being provided by many facilities in Texas, under the FDA Investigational New Drug (IND) enforcement discretion.

The study will provide data to show the effectiveness of Fecal Microbiota Transplant in patients with recurrent Clostridium difficile infection. This study will only examine FMT as it is the only available therapy beyond antibiotic treatment. When patients are considered for FMT they have already failed traditional therapeutic medications.

Patients will be required to meet a specified criteria set forth for chronic or severe CDI infection. Chronic infection is defined as the third or greater episode of C Difficile infection, proven by a positive stool assay with previous documented treatments. Patients must be first treated with first line drug therapies which include vancomycin, metronidazole or fidaxomicin without cure. They must have been treated with at least one course of drugs over a six to eight week period of a vancomycin taper or vancomycin treatment followed by rifaximin for two weeks. Severe CDI infection is defined as refractory moderate to severe CDI diarrhea, with failing vancomycin drug therapy.

Patients with contraindicated co-morbidities will be excluded. Comorbidities include severe bowel disease which would preclude colonoscopy, severe underlying immune suppression or decompensated liver cirrhosis.

Patients will be under the care of a physician who is an identified investigator (sub-investigator) of this study for preparation, procedure and follow up care. Patients will be counseled by this physician regarding the risks and side effects of the procedure and transplant. Staff will only reinforce details from written materials given to patients. Questions outside of the written materials will be directed to the investigators for follow up.