FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff
FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff
Delivery of FMT by upper route, including gastroscopy, nasogastric/ nasojejunal tube, and
 lower route, including retention enema, sigmoidoscopy, or colonoscopy have all been utilized
 successfully. Endoscopic delivery requires significant health care utilization and associated
 cost. Therefore, it is extremely desirable if FMT can be infused by a non invasive modality,
 which would significantly reduce patient discomfort, procedure related risks and health care
 costs, while offering similar efficacy to colonoscopic delivery in the range of 90%.
Patients with minimum 3 episodes of Clostridium difficile within 6 months are randomized 1:1
 to received FMT by either colonoscopy or capsules. Pts are assessed at 1 week, 2 weeks, 1
 mon, 3 mon, 6 mon and 1 year post FMT. Stool, urine and blood samples are collected. Medical
 cost for previous treatment is collected as well at pt perspective and QoL.
Inclusion Criteria:

 1. Age > 18 and < 90 years at the time of Screening.

 2. Diagnosis of at least 3 episodes of recurrent CDI, with each episode defined as
 presence of diarrhea (> 3 unformed stools/24 hours) associate with positive stool
 Clostridium difficle toxin, occurring within 3 months of each other.

 3. CDI infection under symptomatic control with < 3 loose/unformed BM's per 24 h period
 for at least 2 consecutive days before procedure.

 4. Those with ability to provide informed consent.

 Exclusion Criteria:

 1. Those with complicated CDI, defined as white blood cell>35 or <0.5 x 109/L,
 significant abdominal pain and distension with evidence of toxic megacolon or
 pseudomembranous colitis, hypotension defined as systolic blood pressure < 90 mmHg
 unresponsive to fluid resuscitation, end organ failure, or requiring intensive care
 unit admission.

 2. Those with chronic diarrheal illness, such as irritable bowel syndrome or inflammatory
 bowel disease unless they are in remission for at least 3 months prior to enrollment.