Fecal Microbiota Transplantation as a Strategy to Eradicate Resistant Organisms

Conditions

• Infection Resistant to Drugs

Eligibility Criteria

Sex

ALL

Age

7 Years - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Fecal Microbiota Transplantation — BIOLOGICAL
  Fecal Microbiota Transplantation

Study Details

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 Dates

Start date

Feb 17, 2017

Status verified

Sep 2021

Primary completion

Sep 30, 2023

Completion

Sep 30, 2026

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• Experimental: Fecal Microbiota Transplantation
  Subjects will receive 50mL of prepared stool fecal via nasogastric tube

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

• Amanda Adler
  206-884-5086
  [email protected]

Locations (1)

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