Fecal Microbiota Therapy for Recurrent Clostridium Difficile Colitis
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|ClinicalTrials.gov Identifier: NCT01973465|
Recruitment Status : Unknown
Verified October 2013 by John Farrell, OSF Healthcare System.
Recruitment status was: Recruiting
First Posted : October 31, 2013
Last Update Posted : October 31, 2013
This study was developed in response to the July, 2013 FDA draft guidance regarding FMT for CDI. The weight of the evidence in the literature suggests that FMT is the most effective treatment for ambulatory outpatients affected by recurrent CDI who fail conventional therapy.
The anticipated benefits to research patients enrolled in this study include resolution of chronic diarrhea, return of bowel habits and nutritional status to normal, and resolution of chronic recurrent CDI.
FMT involves the endoscopic instillation of freshly obtained stool with millions of live bacteria into the recipient's colon by endoscopic lavage. With any endoscopic procedure, there is a risk of perforated viscous. This is very rare, but the risk is increased with severe CDI. The risk of acquisition of communicable enteric or blood borne pathogen appears to be negligible.
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile||Biological: Stool||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fecal Microbiota Therapy for Recurrent Clostridium Difficile Colitis|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||September 2014|
|Experimental: Fecal Microbiota Therapy||
Implanting fecal matter via colonscope
- Weight and Number of bowel movements/day [ Time Frame: 30 and 90 days ]In the present study we will record each subjects weight and number of bowel movements/day prior to FMT and following FMT at 30 and 90 days.
- Evaluate the most appropriate patient population for FMT [ Time Frame: 30 and 90 days ]Our study will include ambulatory outpatients as well as hospitalized, debillitated patients. FMT has demonstrated effectiveness (both systematic reviews and RCT) for treatment of recurrent Clostridium difficile infection in ambulatory outpatient populations. A secondary outcome of our study is to evaluate stratify our patient population and examine FMT success rates for out two primary outcome measures in outpatients vs. inpatients.
- Determine the overall success of FMT [ Time Frame: 30 and 90 days ]An additional secondary outcome measure will be to examine the percent of patients who undergo 2nd or third FMT. and the success rate (in terms of primary outcome measures) for each subsequent FMT.
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): NCT01973465
|Contact: April A Howarter, BSN||309-624-2409||April.email@example.com|
|United States, Illinois|
|OSF Saint Francis Medical Center||Recruiting|
|Peoria, Illinois, United States, 61637|
|Principal Investigator:||John J Farrell, M.D.||OSF Healthcare System|