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NCT05373784 · ClinicalTrials.gov registry record · Early Phase 1
FMT in Uncomplicated Diverticulitis
A Early Phase 1 study of Diverticulitis and Uncomplicated Diverticular Disease, sponsored by Justin Maykel.
- Active
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05373784 is a Early Phase 1 study of Diverticulitis and Uncomplicated Diverticular Disease that is active but no longer recruiting, run by Justin Maykel. The registered enrollment target is 10 participants, below the 25,234-participant average among 8 other Diverticulitis trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05373784, a Early Phase 1 study of Diverticulitis and Uncomplicated Diverticular Disease, is active but no longer recruiting, sponsored by Justin Maykel.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Fecal Microbiota Transplantation (FMT) is an established treatment for Clostridium difficile (C. diff) infection refractory to medical management. As C. diff infection usually arises due to significant disturbances in the gut microbiome, FMT is typically performed to restore a healthy microbiome among affected patients who have failed other treatments. Diverticulitis is a major, and often recurrent, source of morbidity in the U.S for which antibiotics and surgical resection constitute the only treatment options to date. Although alterations of the intestinal microbiome have also been shown among patients with diverticular disease, research on FMT in diverticulitis is sparse. The intended goal of this project is to determine the feasibility, effectiveness and safety of FMT in the treatment of uncomplicated diverticulitis, using clinical outcomes and microbiome analyses.
Conditions Studied
Interventions
- BIOLOGICAL Fecal Microbiota Transplantation (FMT)
Study Locations (1)
Massachusetts
- UMASS Memorial Medical Center - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-03-15 |
| Est. Completion | 2026-05-30 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05373784
The ClinicalTrials.gov registry entry for NCT05373784 describes a study currently listed as active not recruiting, categorized as Early Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 25,234-participant average among 8 other Diverticulitis trials with a reported enrollment target (100% lower). The listed sponsor is Justin Maykel, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Diverticulitis appearing as the primary indexed condition, and to 1 intervention - of which Fecal Microbiota Transplantation (FMT) is the first listed.
NCT05373784 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05373784 about?
NCT05373784 is a clinical study titled "FMT in Uncomplicated Diverticulitis". Fecal Microbiota Transplantation (FMT) is an established treatment for Clostridium difficile (C. diff) infection refractory to medical management. As C. diff infection usually arises due to significant disturbances in the gut microbiome, FMT is typically performed to restore a healthy microbiome amo...
What is the current status of trial NCT05373784?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2024-03-15. Estimated completion is 2026-05-30.
What conditions does trial NCT05373784 study?
This clinical trial studies the following conditions: Diverticulitis, Uncomplicated Diverticular Disease.
What interventions are being tested in trial NCT05373784?
The interventions under investigation include: Fecal Microbiota Transplantation (FMT) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05373784?
This trial is sponsored by Justin Maykel, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05373784 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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