Recruiting
Phase 1

Fecal Microbiota Transplantation

Sponsor:

Seattle Children's Hospital

Code:

NCT02543866

Conditions

Infection Resistant to Drugs

Eligibility Criteria

Sex: All

Age: 7 - 21

Healthy Volunteers: Not accepted

Interventions

Fecal Microbiota Transplantation

Study Details

Brief 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.

Conditions

Infection Resistant to Drugs

Study ID

NCT02543866

Start date

Feb 17, 2017

Status verified date

Sep, 2021

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 21

Healthy Volunteers: Not accepted

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

-

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Fecal Microbiota Transplantation

Subjects will receive 50mL of prepared stool fecal via nasogastric tube

Interventions

Fecal Microbiota Transplantation

Fecal Microbiota Transplantation

Primary outcome measure

  • Safety and Tolerability of FMT as measured by Incidence, severity, and relatedness of solicited, unsolicited, and serious adverse events [ Time Frame: 12 months post-FMT; optional long-tern follow-up for 5 years post-FMT ]

Central Contacts and Locations

Locations

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Sep 23, 2021

Last verified

Sep, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2021-09-23.