Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02922816 · ClinicalTrials.gov registry record · Phase 1
FMT for MDRO Colonization After Infection in Renal Transplant Recipients
A Phase 1 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT02922816: Clinical Trial Phase 1 study, sponsored by Emory University.
NCT02922816 is a Phase 1 study that was terminated before completion, run by Emory University. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02922816, a Phase 1 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
Transplant patients are at increased risk of colonization and infection with Multidrug Resistant Organisms (MDROs) due to medications that modify their immune systems, increased healthcare and antibiotic exposure, and surgical manipulation of mucosa. In this study, kidney transplant patients who have infections with resistant bacteria will be given a Fecal Microbiota Transplant (FMT), also known as a fecal transplant, after they receive antibiotic treatment. This study will see if FMT will eliminate the resistant bacteria so that the kidney transplant patients do not have to use last resort antibiotics. This Phase 1 pilot study is to obtain preliminary safety data for FMT in renal transplant patients to support the rationale for a subsequent clinical trial, not to establish efficacy or toxicity. This trial is designed to test the safety of FMT, identify clinical outcomes, assess feasibility, and refine the target population in participants with MDRO colonization and intestinal dysbiosis. Data from this study should provide directions for the design of future clinical trials.
Primary Outcome
The safety and feasibility of using FMT in adult participants with Target MDRO colonization after infection will be measured by comparing the number of adverse events (assessed by CTCAE v4.0) after Day 1 of each cycle as compared to baseline.
Interventions
- OTHER Fasting
- BIOLOGICAL Fecal Microbiota Transplant (FMT)
- PROCEDURE Bowel preparation
- PROCEDURE Stool or perirectal swab sampling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2016-12-01 |
| Est. Completion | 2021-12-03 |
| Phase | Phase 1 |
Why NCT02922816 stopped before completion
NCT02922816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 4 interventions - of which Fasting is the first listed.
NCT02922816 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02922816 about?
NCT02922816 is a clinical study titled "FMT for MDRO Colonization After Infection in Renal Transplant Recipients". Transplant patients are at increased risk of colonization and infection with Multidrug Resistant Organisms (MDROs) due to medications that modify their immune systems, increased healthcare and antibiotic exposure, and surgical manipulation of mucosa. In this study, kidney transplant patients who hav...
What is the current status of trial NCT02922816?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2016-12-01. Estimated completion is 2021-12-03.
What interventions are being tested in trial NCT02922816?
The interventions under investigation include: Fasting (OTHER), Fecal Microbiota Transplant (FMT) (BIOLOGICAL), Bowel preparation (PROCEDURE), Stool or perirectal swab sampling (PROCEDURE).
Who is sponsoring clinical trial NCT02922816?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02922816's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03114462 · 11 participants · Phase 1
Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer
- NCT06039709 · 11 participants · Phase 1
Sonodynamic Therapy in Patients With Recurrent GBM
- NCT06425380 · 11 participants · NA
Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
- NCT06472661 · 11 participants · Early Phase 1
FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI