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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: Completed Phase 1 study of Antibiotic Resistant Strain, sponsored by Microbiome Health Research Institute.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants with NIH Grade ≥2 adverse events at Day 7 after randomization.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2017-07-10 |
| Est. Completion | 2019-06-18 |
| Phase | Phase 1 |
What the finished NCT03061097 record still lists
NCT03061097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03061097's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 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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