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FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02254811
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : October 24, 2019
Sponsor:
Collaborator:
University of Calgary
Information provided by (Responsible Party):
Dina Kao, University of Alberta

Study Description
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Brief 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%.

Condition or disease Intervention/treatment Phase
Enterocolitis Clostridium Difficile Recurrent Biological: Fecal Microbiota Transplant Phase 2 Phase 3

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Randomized Trial of Fecal Microbiota Transplantation (FMT) Delivered by Capsule vs Colonoscopy in the Management of Recurrent Clostridium Difficile Infection (CDI)
Actual Study Start Date : September 18, 2014
Actual Primary Completion Date : December 12, 2016
Actual Study Completion Date : September 13, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Delivery via capsule
Fecal microbiota transplant is delivered by oral capsules
 Biological: Fecal Microbiota Transplant
transfer of healthy human gut bacteria to restore the microbiome
Experimental: Delivery via colonoscopy
Fecal microbiota transplant delivered by colonoscopy
 Biological: Fecal Microbiota Transplant
transfer of healthy human gut bacteria to restore the microbiome


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients without recurrent CDI [ Time Frame: 12 weeks after treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254811


Locations
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Canada, Alberta
Foothills Hospital
Calgary, Alberta, Canada, T2N 2T9
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2X8
Sponsors and Collaborators
University of Alberta
University of Calgary
Investigators
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Principal Investigator: Dina Kao, MD University of Alberta
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dina Kao, Associate Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02254811    
Other Study ID Numbers: 48233
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Enterocolitis
Recurrence
Disease Attributes
Pathologic Processes
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases