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NCT02543866 · ClinicalTrials.gov registry record · Phase 1

Fecal Microbiota Transplantation as a Strategy to Eradicate Resistant Organisms

A Phase 1 study of Infection Resistant to Drugs, sponsored by Seattle Children's Hospital.

Recruiting
Registry status
Phase 1
Development phase
20
Enrollment target
1
Study location

NCT02543866: Recruiting Phase 1 study of Infection Resistant to Drugs, sponsored by Seattle Children's Hospital.

NCT02543866 is a Phase 1 study of Infection Resistant to Drugs that is actively recruiting participants, run by Seattle Children's Hospital. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02543866, a Phase 1 study of Infection Resistant to Drugs, is actively recruiting participants, sponsored by Seattle Children's Hospital.

RECRUITING
Registry status
Phase 1
Development phase
20 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Incidence, severity, and relatedness of solicited, unsolicited, and serious adverse events

Interventions

  • BIOLOGICAL Fecal Microbiota Transplantation

Study Locations (1)

Washington

  • Seattle Children's Hospital - Seattle

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2017-02-17
Est. Completion 2026-09
Phase Phase 1
Seattle Children's Hospital

168 total trials

What NCT02543866 shows while recruiting

NCT02543866 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

The record links to 1 condition, with Infection Resistant to Drugs appearing as the primary indexed condition, and to 1 intervention - of which Fecal Microbiota Transplantation is the first listed.

NCT02543866 reports a single indexed study location in Washington.

Frequently Asked Questions

What is clinical trial NCT02543866 about?

NCT02543866 is a clinical study titled "Fecal Microbiota Transplantation as a Strategy to Eradicate Resistant Organisms". 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 Enterobacter...

What is the current status of trial NCT02543866?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2017-02-17. Estimated completion is 2026-09.

What conditions does trial NCT02543866 study?

This clinical trial studies the following conditions: Infection Resistant to Drugs.

What interventions are being tested in trial NCT02543866?

The interventions under investigation include: Fecal Microbiota Transplantation (BIOLOGICAL).

Who is sponsoring clinical trial NCT02543866?

This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02543866 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT02543866's enrollment target sits among peer trials

20 1630th of 2000 higher than 285 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02543866, the US trial registry maintained by the National Library of Medicine. NCT02543866 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.