CompletedPhase 2/3

FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff

Canada116 participantsStarted 2014-09-18

Plain-language summary

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%.

Who can participate

Age range18 Years – 90 Years

SexALL

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Inclusion criteria

✓. Age \> 18 and \< 90 years at the time of Screening.
✓. 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.
✓. CDI infection under symptomatic control with \< 3 loose/unformed BM's per 24 h period for at least 2 consecutive days before procedure.
✓. Those with ability to provide informed consent.

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

Proportion of patients without recurrent CDI

Timeframe: 12 weeks after treatment

Trial details

NCT IDNCT02254811

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12-12

View on ClinicalTrials.gov More Enterocolitis Clostridium Difficile Recurrent trials