Fresh Versus Frozen Stool for Fecal Transplant in Children
Fresh Versus Frozen Stool for Fecal Transplant in Children
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.
The study is designed to enroll forty children aged 1-18 with recurrent Clostridium difficile
 Infection (CDI). Recurrent CDI is defined as an infection that persists after three rounds of
 appropriate antibiotics. Enrollees will be randomly assigned to receive Fecal Microbial
 Transplant using stool from either a screened relative as per current protocols versus using
 frozen stool that has been collected from healthy volunteers.

 Primary outcome will be the eradication of the Clostridium difficile as defined by
 elimination of diarrhea with a negative Clostridium difficile toxin stool test.

 Secondary outcomes will include a measure of quality of life pre and post Fecal Microbial
 Transplant using a validated quality of life survey instrument, the Health Act Child Health
 Questionnaire. The investigators will also assess for inflammation in the stool using
 lactoferrin and calprotectin and evaluate the stool microbiome in recipients pre and post
 transplant using sequencing to look for any pattern that predicts successful eradication.
Eligible children between aged 1 and 18 years must have had Clostridium difficile infection
 that has not been eradicated despite at least two courses of antibiotics ( either
 metronidazole or vancomycin).

 Inclusion criteria:

 -  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.

 Exclusion Criteria:

 -  Age under 1 or over 18

 -  No diarrhea