Trial | NCT01972334  Report issue

Title

Stool Transplant in Pediatric Patients With Recurring C. Difficile Infection
A Randomized, Placebo-controlled Pilot Trial to Administer Fecal Microbial Therapy (Stool Transplant) or Placebo in Children Ages 8 to 18 With Recurrent C. Difficile Infection

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    FMT ...

  • Study Participants

    9
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.
Forty six children with recurrent C. difficle infection will be randomized 1:1 to receive either fecal microbial transplant or placebo. The safety and efficacy of this intervention will be monitored for one year.
Study Started
Oct 31
2013
Primary Completion
Jul 31
2016
Study Completion
Jul 31
2016
Last Update
Sep 01
2016
Estimate

Biological FMT

as explained in study arm

  • Other names: fecal microbial transplant, stool transplant

Biological placebo

salt water or saline will be given as placebo

  • Other names: saline, salt water

FMT or fecal microbial transplant Experimental

intervention is fecal microbial transplant done through endoscopy, subjects will be randomized 1:1 to receive either FMT or placebo

  • Biological FMT

placebo Placebo Comparator

1:1 randomization to FMT versus placebo (which is saline or salt water)

Criteria 

Inclusion Criteria:

Age: 1-21.
Recurrent C. difficile infection defined as the occurrence of more than two infections

Exclusion Criteria:

Inflammatory bowel disease
Immune-deficiency.
Allergy to oral vancomycin.
Children colonized with Clostridium difficile without evidence of symptoms to suggest colitis such as diarrhea and/or rectal bleeding.
Concurrent infections that require anti-microbial therapy.
Unable to give informed consent/assent.
Pregnancy.
No Results Posted