Early FMT for C.Difficile

Treatment of CDI remains challenging, especially in those with recurrent disease. Failures rates of 20-30% with initial treatment have been reported, and up to 65% fail after a third course of antibiotics. In addition, costs of treatment, which can be upward of $3000 for a 10 day course of a single antibiotic, may leave many patients and their families financially overburdened. Use of FMT has shown to be effective with cure rates above 80%, safe even in immunocompromised patients, and cost effective in those with recurrent (3 or more) episodes of C.difficile. Emory University and Emory Clinic have performed over 100 FMT's since July 2012 for treatment of recurrent or refractory CDI and has had similar cure rates.

Current treatment approaches for CDI limit the use of fecal transplant to those who have had more than 2 recurrences with at least one failure of a 6-8 week taper with vancomycin or at least 2 episodes of severe CDI resulting in hospitalization or refractory CDI defined as moderate CDI not responding to standard therapy for at least one week (5). However, the investigators feel that by attempting to perform FMT early after a first episode in those at high risk of recurrence, decreased recurrence rates, improved quality of life, and lower health care costs will be seen.

Patients who participate will be randomized to one of two groups - one group who receives a fecal transplant and another group who will not receive a fecal transplant. A fecal transplant using a sigmoidoscopy will occur after the subjects in the fecal transplant arm complete the course of antibiotics for treatment of the C.difficile infection. Healthy stool from a donor will be infused into the colon to help replenish good bacteria that patients with C.difficile infection often do not have. The group that does not undergo FMT will take antibiotics and probiotic therapy for management of CDI as part of standard of care.

Inclusion criteria

Patients must meet all of the following criteria to be eligible for the study:

• First or second episode of CDI responding to therapy
• Must have 2 or more of the following criteria:

• Age >65
• Severe underlying disease (measured by Horn index score of 3 or 4)
• Additional non-C.difficile antibiotic exposure during CDI episode
• Use of antacids
• Previous episode of CDI
• Willingness to accept a fecal product made using unrelated donor stool and to comply with study protocol requirements
• Able to give informed consent
• Chronic infection with HIV, HBV, HCV is permitted unless the viral infection compromises the ability of the patient to safely participate in the study. Patients with a CD4 count <200 and/ or AIDS defining illness or decompensated cirrhosis will not be eligible for the study.
• Life expectancy >4 months

Exclusion criteria

• Any of the following: acute leukemia, history of allogenic or recent (within 6 months) autologous bone marrow transplant, or use of cytotoxic chemotherapy within 2 months
• ANC <1000/mm^3
• History of inflammatory bowel disease
• History of total colectomy
• Pregnant or nursing mothers
• History of significant food allergy to foods not excluded from the donor diet
• Patient has any other condition that, in the opinion of the Investigator, would jeopardize the safety or rights of the subject participating in the study, would make it unlikely for the subject to complete the study, or would confound the results of the study
• Patients who are aged 80 years or greater
• Patients who are incarcerated
• Patient with cognitive impairment or severe neuropsychiatric co morbidities who are incapable of giving consent
• Inherited/primary immune disorders
• Patients who are unwilling or unable to undergo sigmoidoscopy
• Unable to comply with protocol requirements
• Patients with untreated, in-situ colorectal cancer