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Harnessing the Healthy Gut Microbiota to Cure Patients With Recurrent C. Difficile Infection

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ClinicalTrials.gov Identifier: NCT01372943
Recruitment Status : Unknown
Verified October 2015 by Dr. Elaine Petrof, Queen's University.
Recruitment status was:  Active, not recruiting
First Posted : June 14, 2011
Last Update Posted : October 21, 2015
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Dr. Elaine Petrof, Queen's University

Brief Summary:
CDI (Clostridium difficile infection) causes diarrheal illness and can cause colitis which may be fatal. A patient being treated for CDI has a 10-25% chance of developing relapse. Recurrent CDI is on the rise. There are few options available to treat recurrent CDI. "Stool transplant" (infusing donor stool into the intestine of the recipient), is not very palatable to either patient or medical personnel. The investigators will isolate intestinal bacteria from donor stool and use this purified mixture of donor bacteria instead of stool transplant. The investigators hypothesize that this cleaner mixture of purely isolated intestinal bacteria from a healthy donor would be equally effective as conventional fecal bacteriotherapy, which uses donor stool. The use of this prepared mixture of aerobic and anaerobic organisms, or probiotic approach, is based on the same principle of fecal flora reconstitution. However our approach would provide a more controlled, reproducible, cleaner and more aesthetically acceptable method of administration, and from a patient safety perspective, would also be a safer strategy than using freshly defecated donor fecal matter.

Condition or disease Intervention/treatment
Clostridium Difficile Infection Biological: "synthetic stool" or pure cultures of probiotic intestinal bacteria

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study Using "Synthetic Stool" or Pure Cultures of Probiotic Intestinal Bacteria From Healthy Donor Stool That Can be Used as an Enema to Replace the Use of Stool Transplant, for Treatment of Recurrent and Refractory CDI
Study Start Date : January 2010
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Arm Intervention/treatment
Experimental: synthetic stool
"synthetic stool" or pure cultures of probiotic intestinal bacteria from healthy donor stool that can be used as an enema to replace the use of stool transplant, for treatment of recurrent and refractory CDI
Biological: "synthetic stool" or pure cultures of probiotic intestinal bacteria
"synthetic stool" or pure cultures of probiotic intestinal bacteria from healthy donor stool that can be used as an enema to replace the use of stool transplant, for treatment of recurrent and refractory CDI



Primary Outcome Measures :
  1. number of participants cured of CDI [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with recurrent CDI that have failed standard therapy

Exclusion Criteria:

  • critically ill patients

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): NCT01372943


Locations
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Queen's University
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Elaine Petrof, MD Kingston General Hospital

Responsible Party: Dr. Elaine Petrof, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT01372943     History of Changes
Other Study ID Numbers: DMED 1318-10
First Posted: June 14, 2011    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: October 2015

Keywords provided by Dr. Elaine Petrof, Queen's University:
Clostridium difficile
recurrent
infection

Additional relevant MeSH terms:
Infection
Communicable Diseases