Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection (FMT)
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|ClinicalTrials.gov Identifier: NCT02326636|
Recruitment Status : Recruiting
First Posted : December 29, 2014
Last Update Posted : October 27, 2016
|Condition or disease||Intervention/treatment|
|Clostridium Difficile Infection||Biological: Fecal Microbial Transplantation|
|Study Type :||Observational|
|Estimated Enrollment :||76 participants|
|Official Title:||Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||May 2018|
Biological: Fecal Microbial Transplantation
- The recurrence rate of Clostridium difficile 4 weeks after FMT. [ Time Frame: Four weeks ]
- Clinical symptoms from before fecal microbiota transplant (FMT) to 4 weeks after FMT. [ Time Frame: Four weeks ]
- Satisfaction with the FMT procedure. ( satisfaction questionnaire ) [ Time Frame: Up to 24 weeks ]Subjects will complete a satisfaction questionnaire following the FMT procedure.
- Quality of life before and 4 weeks after FMT. [ Time Frame: Four weeks ]Subjects will complete a quality of life questionnaire before and 4 weeks after FMT.
- Alternate treatments needed for Clostridium difficile before and after FMT. [ Time Frame: Up to 24 weeks ]Subjects medication and treatment history for Clostridium difficile before and after FMT will be collected.
- The rate of adverse events that may be related to FMT. [ Time Frame: Up to 24 weeks ]
Biospecimen Retention: Samples Without DNA
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): NCT02326636
|Contact: Douglas O'Connell, MS||7144567033||Douglaeo@uci.edu|
|Contact: Sentelle Eubanksfirstname.lastname@example.org|
|United States, California|
|University of California, Irvine Medical Center||Recruiting|
|Orange, California, United States, 92868|
|Contact: Douglas O'Connell, MS 714-456-7033 Douglaeo@uci.edu|
|Principal Investigator:||Nimisha Parekh, MD||University of California, Irvine|