Stool Transplant in Pediatric Patients With Recurring C. Difficile Infection

MemorialCare Health System

Status and phase: Completed; Phase 2

Conditions: Clostridium Difficile Colitis

Treatments: Biological: FMT; Biological: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01972334

093-12

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 9 patients

Sex: All

Ages: 1 to 21 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Inflammatory bowel disease
2. Immune-deficiency.
3. Allergy to oral vancomycin.
4. Children colonized with Clostridium difficile without evidence of symptoms to suggest colitis such as diarrhea and/or rectal bleeding.
5. Concurrent infections that require anti-microbial therapy.
6. Unable to give informed consent/assent.
7. Pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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9 participants in 2 patient groups, including a placebo group

FMT or fecal microbial transplant

Experimental group

Description:

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

Treatment:

Biological: FMT

placebo

Placebo Comparator group

Description:

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

Treatment:

Biological: placebo