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NCT05911997 · ClinicalTrials.gov registry record · Phase 1
MTC Versus FMT in for RCDI
A Phase 1 study of Clostridiodies Difficile Infections, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05911997: Recruiting Phase 1 study of Clostridiodies Difficile Infections, sponsored by Icahn School of Medicine at Mount Sinai.
NCT05911997 is a Phase 1 study of Clostridiodies Difficile Infections that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05911997, a Phase 1 study of Clostridiodies Difficile Infections, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Investigating four different treatment of MTC or FMT
Primary Outcome
Number of serious adverse events per NIH grading indications. Grade 1-5, where grade 3-5 are considered severe. 1. Mild 2. Moderate 3. Severe 4. Life threatening 5. Death Serious Adverse Event (SAE): Any adverse event that: * Results in death * Is life threatening, or places the participant at immediate risk of death from the event as it occurred * Requires or prolongs hospitalization * Causes persistent or significant disability or incapacity * Results in congenital anomalies or birth defect
Conditions Studied
Interventions
- DRUG MTC 01
- DRUG Fecal Microbiota Transplantation (FMT)
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-01-08 |
| Est. Completion | 2026-07-25 |
| Phase | Phase 1 |
What NCT05911997 shows while recruiting
NCT05911997 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 1 condition, with Clostridiodies Difficile Infections appearing as the primary indexed condition, and to 2 interventions - of which MTC 01 is the first listed.
NCT05911997 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05911997 about?
NCT05911997 is a clinical study titled "MTC Versus FMT in for RCDI". Investigating four different treatment of MTC or FMT
What is the current status of trial NCT05911997?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2024-01-08. Estimated completion is 2026-07-25.
What conditions does trial NCT05911997 study?
This clinical trial studies the following conditions: Clostridiodies Difficile Infections.
What interventions are being tested in trial NCT05911997?
The interventions under investigation include: MTC 01 (DRUG), Fecal Microbiota Transplantation (FMT) (DRUG).
Who is sponsoring clinical trial NCT05911997?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05911997 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05911997's enrollment target sits among peer trials
60 832nd of 2000 higher than 1,106 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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