Fecal Microbiota Transplantation as a Strategy to Eradicate Resistant Organisms

This is a prospective pilot study of fecal microbiota transplantation in pediatric patients
with a history of ESC-R Enterobacteriaceae. Subjects who meet inclusion/exclusion criteria
and provide written, informed consent will undergo screening studies and provide a pre-FMT
stool sample to confirm intestinal carriage of ESC-R Enterobacteriaceae. The FMT will be
administered by nasogastric tube in the outpatient setting by trained personnel. The subjects
will be monitored for potential adverse events, recurrence of MDRO infections, infections
that may be related to FMT, and worsening of existing comorbidities or development of new
comorbidities for the 12 months post-FMT with the option of participating in long-term
follow-up for up to 5 years post-FMT. Patients will provide stool samples 2 days, 2 weeks, 4
weeks, 8 weeks, 6 months, and 12 months post-FMT. These samples will be testing for ESC-R
Enterobacteriaceae.

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