Fecal Transplant for Pediatric Patients Who Have Recurrent C-diff Infection (FMT)
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|ClinicalTrials.gov Identifier: NCT02134392|
Recruitment Status : Recruiting
First Posted : May 9, 2014
Last Update Posted : July 7, 2020
C-diff infection often causes belly pain and diarrhea and can be very hard to treat with medicine. One of the possible reasons that C-diff infection is hard to treat is because there is too much "bad" bacteria in the colon. Investigators believe that putting more "good" bacteria into the colon will help fight the "bad" bacteria. We do this by doing a fecal (poop) transplant.
Fecal transplant has been done at other hospitals, but not at Nationwide Children's Hospital. Since our Investigators have not done this before, this study will help us learn the best way to do the transplant. Investigators also believe this transplant might help improve symptoms for patients with C-diff.
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile||Biological: Fecal Microbiota Transplantation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fecal Microbiota Transplantation (FMT) for Recurrent or Refractory C. Difficile Infection (CDI) in Pediatric and Young Adult Patients|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
Experimental: Fecal Microbiota Transplantation
250 ml of a fecal suspension diluted in saline given by colonoscopy or enema.
Biological: Fecal Microbiota Transplantation
250 ml of a fecal suspension diluted in saline will be administered via colonoscopy or enema in patients with recurrent c-diff.
- Resolution of C. difficile [ Time Frame: 6 months post transplant ]The primary objective of the study is to establish the cure rate of C. difficile infection in pediatric patients.
- Adverse events [ Time Frame: Six months post transplant ]Follow up phone calls will be made at days 1, 7, 14, and months 1 and 6 to determine whether adverse events have occurred.
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): NCT02134392
|Contact: Ling Fan, MPHfirstname.lastname@example.org|
|United States, Ohio|
|GI Division, Nationwide Children's Hospital||Recruiting|
|Columbus, Ohio, United States, 43205|
|Contact: Jonathan M. Gisser, M.D. 614-355-2858 email@example.com|
|Principal Investigator: Jonathan M. Gisser, M.D.|
|Principal Investigator:||Jonathan M. Gisser, M.D.||Nationwide Children's Hospital|