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NCT03061097 · ClinicalTrials.gov registry record · Phase 1

Autologous Fecal Microbiota Transplantation to Prevent Antibiotic Resistant Bacteria Colonization

A Phase 1 study of Antibiotic Resistant Strain, sponsored by Microbiome Health Research Institute.

Completed
Registry status
Phase 1
Development phase
7
Enrollment target
1
Study location

NCT03061097 is a Phase 1 study of Antibiotic Resistant Strain that has completed, run by Microbiome Health Research Institute. The registered enrollment target is 7 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT03061097, a Phase 1 study of Antibiotic Resistant Strain, has completed, sponsored by Microbiome Health Research Institute.

COMPLETED
Registry status
Phase 1
Development phase
7 participants
Enrollment target
1
Study location

Study Summary

This study, a Randomized controlled trial of Autologous microbiome reconstitution to prevent Colonization by antibiotic rEsistant bacteria (RACE), seeks to investigate the safety, feasibility and the role of autologous fecal microbiota transplantation (FMT) for the prevention of antibiotic resistant bacteria (ARB) through microbiome restoration.

Interventions

  • BIOLOGICAL Autologous fecal microbiota transplant (Auto-FMP Enema)
  • OTHER Placebo Enema Preparation

Study Locations (1)

Massachusetts

  • Boston University - Boston Medical Center nursing home consortium - Boston

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2017-07-10
Est. Completion 2019-06-18
Phase Phase 1

What the Registry Record Tells You About NCT03061097

The ClinicalTrials.gov registry entry for NCT03061097 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Microbiome Health Research Institute, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Antibiotic Resistant Strain appearing as the primary indexed condition, and to 2 interventions - of which Autologous fecal microbiota transplant (Auto-FMP Enema) is the first listed.

NCT03061097 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT03061097 about?

NCT03061097 is a clinical study titled "Autologous Fecal Microbiota Transplantation to Prevent Antibiotic Resistant Bacteria Colonization". This study, a Randomized controlled trial of Autologous microbiome reconstitution to prevent Colonization by antibiotic rEsistant bacteria (RACE), seeks to investigate the safety, feasibility and the role of autologous fecal microbiota transplantation (FMT) for the prevention of antibiotic resistant...

What is the current status of trial NCT03061097?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2017-07-10. Estimated completion is 2019-06-18.

What conditions does trial NCT03061097 study?

This clinical trial studies the following conditions: Antibiotic Resistant Strain.

What interventions are being tested in trial NCT03061097?

The interventions under investigation include: Autologous fecal microbiota transplant (Auto-FMP Enema) (BIOLOGICAL), Placebo Enema Preparation (OTHER).

Who is sponsoring clinical trial NCT03061097?

This trial is sponsored by Microbiome Health Research Institute, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03061097 being conducted?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.