Fresh Versus Frozen Stool for Fecal Transplant in Children
Condition: Clostridium Difficile
MeSH terms: Clostridium Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Transplant uses frozen anonymous stool; Transplant uses fresh familial stool
Intervention type(s): Biological; Biological
Intervention description(s): The intervention is using frozen anonymous donor stool instead of fresh stool from family members for the fecal microbial transplant to treat recurrent CDI.; The intervention is using fresh familial donor stool for the fecal microbial transplant to treat recurrent CDI
Other intervention name(s): fecal microbial transplant; fecal microbila transplant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment