Fecal Microbiota Transplantation as a Strategy to Eradicate Resistant Organisms

Recruiting now · Phase 1

Conditions studied: Infection Resistant to Drugs

In brief

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.

Key facts

Study ID

NCT02543866

Run by

Seattle Children's Hospital

People needed

20

Starts

2017-02-17

Expected to finish

2026-09-01

Last updated by the study team

2021-09-23

Who can join

Age: 7 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Seattle Children's Hospital — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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