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RecruitingPhase 1NCT02543866

Fecal Microbiota Transplantation as a Strategy to Eradicate Resistant Organisms

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

Sponsor

Seattle Children's Hospital

Enrollment

20 participants

Start Date

Feb 17, 2017

Study Type

INTERVENTIONAL

Conditions

Infection Resistant to Drugs

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.

Eligibility

Min Age: 7 YearsMax Age: 21 Years

Inclusion Criteria4

  • Children and adolescents between 7 and 21 years of age.
  • 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.
  • Parent/guardian and participant must be able to attend baseline and follow-up study visits.
  • Subject must be willing and able to provide written informed consent or assent (as appropriate by age).

Exclusion Criteria14

  • 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.
  • 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.
  • Lack of intestinal carriage of ESC-R Enterobacteriaceae (negative selective stool culture for ESC-R Enterobacteriaceae).
  • Allergy or hypersensitivity to omeprazole and polyethylene glycol.
  • Pregnancy.
  • Current history of frequent (>1 per week) vomiting.
  • Active inflammatory gastrointestinal disease, such as inflammatory bowel disease
  • Active mucositis or acute graft versus host disease of the gastrointestinal tract
  • Concurrent abdominal radiation therapy.
  • Inability to tolerate nasogastric tube placement or contraindication to having an NG tube placed.
  • 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.
  • Bleeding diatheses
  • Patients with current active ESC-R Enterobacteriaceae infection who have not yet completed antibiotic treatment will be excluded until their treatment is completed
  • \-

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Interventions

BIOLOGICALFecal Microbiota Transplantation

Fecal Microbiota Transplantation

Locations(1)

Seattle Children's Hospital

Seattle, Washington, United States

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NCT02543866