Fecal Microbiota Transplantation as a Strategy to Eradicate Intestinal Carriage of Resistant Organisms
Seattle Children's Hospital
Summary
This protocol will evaluate fecal microbiota transplantation (FMT) as a strategy to eradicate intestinal colonization of extended-spectrum resistant (ESC-R) Enterobacteriaceae in pediatric patients. FMT will be performed on subjects with a history of at least one infection due to ESC-R Enterobacteriaceae. This protocol aims to determine the feasibility, safety, tolerability, and potential efficacy of FMT in pediatric patients with a history of ESC-R Enterobacteriaceae.
Description
This is a prospective pilot study of fecal microbiota transplantation in pediatric patients with a history of ESC-R Enterobacteriaceae. Subjects who meet inclusion/exclusion criteria and provide written, informed consent will undergo screening studies and provide a pre-FMT stool sample to confirm intestinal carriage of ESC-R Enterobacteriaceae. The FMT will be administered by nasogastric tube in the outpatient setting by trained personnel. The subjects will be monitored for potential adverse events, recurrence of MDRO infections, infections that may be related to FMT, and worsening of existing…
Eligibility
- Age range
- 7–21 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Children and adolescents between 7 and 21 years of age. 2. A history at least one infection due to ESC-R Enterobacteriaceae. ESC-R isolates will be defined as those non-susceptible to ceftriaxone, cefotaxime, or ceftazidime. 3. Parent/guardian and participant must be able to attend baseline and follow-up study visits. 4. Subject must be willing and able to provide written informed consent or assent (as appropriate by age). Exclusion Criteria: 1. Patients with any history of malignancy or any immunocompromised state (e.g. absolute neutrophil count outside the normal ra…
Interventions
- BiologicalFecal Microbiota Transplantation
Fecal Microbiota Transplantation
Location
- Seattle Children's HospitalSeattle, Washington