RECRUITING

Fecal Microbiota Transplantation as a Strategy to Eradicate Resistant Organisms

Description

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.

Study Overview

Study Details

Study overview

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.

Fecal Microbiota Transplantation as a Strategy to Eradicate Intestinal Carriage of Resistant Organisms

Fecal Microbiota Transplantation as a Strategy to Eradicate Resistant Organisms

Condition
Infection Resistant to Drugs
Intervention / Treatment

-

Contacts and Locations

Seattle

Seattle Children's Hospital, Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • 1. Patients with any history of malignancy or any immunocompromised state (e.g. absolute neutrophil count outside the normal range) induced by disease or therapy will be excluded.
  • 2. Patients with past or current use of systemic immunosuppressive agents will be excluded. Receipt of non-systemic agents such as inhaled, nasal, or topical steroids or immune-modulating agents are allowed.
  • 3. Lack of intestinal carriage of ESC-R Enterobacteriaceae (negative selective stool culture for ESC-R Enterobacteriaceae).
  • 4. Allergy or hypersensitivity to omeprazole and polyethylene glycol.
  • 5. Pregnancy.
  • 6. Current history of frequent (\>1 per week) vomiting.
  • 7. Active inflammatory gastrointestinal disease, such as inflammatory bowel disease
  • 8. Active mucositis or acute graft versus host disease of the gastrointestinal tract
  • 9. Concurrent abdominal radiation therapy.
  • 10. Inability to tolerate nasogastric tube placement or contraindication to having an NG tube placed.
  • 11. Presence of a ventriculoperitoneal shunt or other intrabdominal device, receipt of renal dialysis, presence of ascites, or other conditions/devices that would increase the risk of peritonitis.
  • 12. Bleeding diatheses
  • 13. Patients with current active ESC-R Enterobacteriaceae infection who have not yet completed antibiotic treatment will be excluded until their treatment is completed

Ages Eligible for Study

7 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Seattle Children's Hospital,

Danielle Zerr, MD, MPH, PRINCIPAL_INVESTIGATOR, Seattle Children's Hospital

Study Record Dates

2026-09