Fresh Versus Frozen Stool for Fecal Transplant in Children
Completed · Phase 1
Conditions studied: Clostridium Difficile
In brief
The primary goal of this study will be to assess whether stool collected and frozen from anonymous screened unrelated donors can be as effective as stool freshly collected from recipient's parents when used in Fecal Microbial Transplant for the eradication of recurrent Clostridium difficile infections in children. In the current protocols, which are more than 90% effective, each child who is receiving a fecal transplant has to provide their own donor stool, usually from a parent or close relative. This requires considerable screening costs for each case and is logistically complicated as the donor must be present and must stool just prior to the transplant. The investigators hope to show that a small number of healthy donors can provide stool samples which can be frozen and banked and then thawed for use in numerous patients. The primary goal is to show that Clostridium difficile will be eradicated as effectively (Greater than 90% success) when using the stool from the frozen donors. The study will also evaluate the inflammatory response and intestinal microbiome in young children aged 1-3 years with Clostridium difficile infections to better predict which ones will respond to fecal transplantation and which ones have incidental infections. For this question the investigators will gather stool samples to check for lactoferrin, calprotectin, and alpha1antitrypsin, and 16s ribosomal RNA analysis in children before and after the fecal transplants. The goal is to see if there is an intestinal microbiome that predisposes some children to getting sick from Clostridium difficile versus just having it incidentally.
Key facts
- Study ID
- NCT02423967
- Run by
- Mayo Clinic
- People needed
- 28
- Starts
- 2015-04-01
- Expected to finish
- 2019-03-04
- Last updated by the study team
- 2019-03-06
Who can join
Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 1-18 years
- Diarrhea
- Positive Clostridium difficile infection using stool toxin testing
- Diarrhea that has improved on antibiotics but recurs when antibiotics are stopped.
- Willingness to undergo Fecal Microbial Transplant using frozen stool from anonymous screened donors.
You may not qualify if…
- Age under 1 or over 18
- No diarrhea
Where it is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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