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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Negative c-difficile test [ Time Frame: 30 days ]Enrolled patients will test negative for c-difficile following application of the study intervention
- Relief of symptoms [ Time Frame: 30 days ]patient report of decrease in symptoms related to c-difficile
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
|Contact: Robert B Moghimi, MDfirstname.lastname@example.org|
|Contact: Sherri Mendelson, PhD, RN||818-496-4390||Sherri.email@example.com|
|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.firstname.lastname@example.org|
|Contact: Kelly Pagel, RN, BSN 818-365-8051 Kelly.email@example.com|
|Principal Investigator: Robert Moghimi, MD|
|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|