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Fecal Microbiota Transplantation as a Strategy to Eradicate Resistant Organisms

RecruitingPhase 1

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

Who can join

Ages 7 to 21 · All sexes

Full eligibility criteria
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

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About the study

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.

What is being tested

Sponsor: Seattle Children's Hospital · Participants: 20 · Started: Feb 17, 2017

Contact the study team

Official record on ClinicalTrials.gov — NCT02543866

Locations in the U.S.

WashingtonSeattle Children's Hospital, Seattle

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.