Stool Transplant in Pediatric Patients With Recurring C. Difficile Infection

The incidence of C. difficile infection (CDI) has alarmingly increased over the past several
years and the affected population has expanded to include those previously at low risk, such
as children. The annual US financial burden associated with this infection is great and
estimated to exceed $1.8 billion. C. difficile infection arises when the gut microbial
ecology is disrupted during interventions notorious for perturbing the delicate microbial
balance. A well known and common example is the use of antibiotics. Fecal microbiota
transplant (FMT) has been introduced several decades ago in an attempt to restore the gut
microbial balance. To this date there have been a great number of reports of success in
eliminating recurrent C. difficile infections and restoring the gut microbial profile to
resemble that of the healthy donor. While over 300 cases have been described in the
literature, there has been no pediatric controlled studies performed to compare its efficacy
to placebo. Therefore, there is a strong need to determine their safety and efficacy in
pediatric randomized controlled studies. The investigators hypothesize that children with
recurrent C. difficile infection will respond to fecal transplant therapy which will modify
their gut microbial profile. The investigators propose a randomized, placebo controlled,
pilot study of fecal microbial transplant in children with recurrent C. difficile infection
to evaluate the safety and efficacy of fecal microbial transplant in children in preventing
recurrent C. difficile infection. The investigators anticipate that fecal microbial
transplant in children with recurrent C. difficile infection will be safe and efficacious
and will provide these children with a great alternative to a disease that is difficult to
treat. Results of this study will establish the major role of the gut microbiome in this
disease and demonstrate the viability of gut microbial transplant in recipients.