Fecal Microbiota Transplantation as a Strategy to Eradicate Resistant Organisms
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.
Conditions:
🦠 Infection Resistant to Drugs
🗓️ Study Start (Actual) 17 February 2017
🗓️ Primary Completion (Estimated) September 2023
✅ Study Completion (Estimated) September 2026
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Seattle, Washington, United States

📋 Eligibility Criteria

Description

    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 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 (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 4 September 2015
  • First Submitted that Met QC Criteria 4 September 2015
  • First Posted 7 September 2015

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 September 2021
  • Last Update Posted 23 September 2021
  • Last Verified September 2021