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FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff

NCT02254811 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2019-10-24

No results posted yet for this study

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%.

Conditions

  • Enterocolitis Clostridium Difficile Recurrent

Interventions

BIOLOGICAL

Fecal Microbiota Transplant

transfer of healthy human gut bacteria to restore the microbiome

Sponsors & Collaborators

  • University of Calgary

    collaborator OTHER

  • University of Alberta

    lead OTHER

Principal Investigators

  • Dina Kao, MD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-18
Primary Completion
2016-12-12
Completion
2017-09-13

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02254811 on ClinicalTrials.gov