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Reduction of C-Difficile Infection Using Stool Transplant (FMT)

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ClinicalTrials.gov Identifier: NCT02112279
Recruitment Status : Unknown
Verified January 2015 by Sherri Mendelson, Providence Holy Cross Medical Center.
Recruitment status was:  Recruiting
First Posted : April 11, 2014
Last Update Posted : January 8, 2015
Sponsor:
Information provided by (Responsible Party):
Sherri Mendelson, Providence Holy Cross Medical Center

Brief Summary:

Clostridium-difficile (C-difficile) is a gram positive anaerobic spore-forming bacterium that can lead to severe diarrhea and pseudomembranous colitis. According to Schroeder (2005), there are approximately 3 million cases annually with a mortality rate of 1-2.5 %. It is most often associated with overuse of antibiotics. According to Bartlett & Gerding (2008), 15-25% of anti-microbial-associated diarrhea is caused by C-difficile.

The purpose of this study is to determine if donor fecal microbiota transplant via colonoscopy reduces refractory C-difficile infection better than current routine methods such as continued antibiotic treatment. Specifically, we hypothesize that fecal microbiota transplant via colonoscopy will result in a higher C-difficile cure rate in affected patients versus care as usual in a retrospective cohort.


Condition or disease Intervention/treatment Phase
C-difficile Biological: Donor microbiota applied via colonoscopy. Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reduction of C-Difficile Infection Using Fecal Microbiota Transplant
Study Start Date : April 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Microbiota Transplant
Close relative or purchased donor microbiota transplant will be administered via colonoscopy; Donor microbiota applied via colonoscopy
Biological: Donor microbiota applied via colonoscopy.

B. Preparation of donor sample 1. Instillation via Colonoscopy

1. Stool mixture is administered into the terminal ileum and cecum through the biopsy channel of a colonoscope while the patient is sedated.

Administer 300-700 ml of slurry through biopsy channel of colonoscope with a piston syringe.





Primary Outcome Measures :
  1. Negative c-difficile test [ Time Frame: 30 days ]
    Enrolled patients will test negative for c-difficile following application of the study intervention


Secondary Outcome Measures :
  1. Relief of symptoms [ Time Frame: 30 days ]
    patient report of decrease in symptoms related to c-difficile



Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patients must be 18 years of age or older
  2. Patient must have a positive C. difficile test within the 10 days prior to the procedure
  3. Continued symptoms of c-difficile infection
  4. Patients must have failed at least two courses of appropriate antibiotic therapy for C. diff to be a candidate for this procedure

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Exclusion Criteria:

  1. Under 18 years of age
  2. Negative C. difficile test within the 10 days prior to the procedure
  3. No symptoms of c-difficile infection
  4. Less than two courses of appropriate antibiotic therapy for C. difficile infection

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): NCT02112279


Contacts
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Contact: Robert B Moghimi, MD 818-363-7120 rbm10105@yahoo.com
Contact: Sherri Mendelson, PhD, RN 818-496-4390 Sherri.mendelson@providence.org

Locations
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United States, California
Providence Holy Cross Medical Center Recruiting
Mission Hills, California, United States, 91345
Contact: Sherri G Mendelson, RN, PhD    818-496-4390    Sherri.mendelson@providence.org   
Contact: Kelly Pagel, RN, BSN    818-365-8051    Kelly.pagel@providence.org   
Principal Investigator: Robert Moghimi, MD         
Sponsors and Collaborators
Providence Holy Cross Medical Center
Investigators
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Principal Investigator: Robert B Moghimi, MD PHCMC
Principal Investigator: Ellsworth Pryor, MD Providence Holy Cross Medical Center
Principal Investigator: Sherri G Mendelson, RN, PhD Providence Holy Cross Medical Center
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Responsible Party: Sherri Mendelson, Director Nursing Research and Magnet Program, Providence Holy Cross Medical Center
ClinicalTrials.gov Identifier: NCT02112279    
Other Study ID Numbers: PHC059
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: January 8, 2015
Last Verified: January 2015
Keywords provided by Sherri Mendelson, Providence Holy Cross Medical Center:
Microbiota
c-difficile
colonoscopy
stool transplant
Additional relevant MeSH terms:
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Infection