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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: Active Early Phase 1 study of Diverticulitis and Uncomplicated Diverticular Disease, sponsored by Justin Maykel.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
After FMT, recipients/participants will be asked to report the number of diverticulitis episodes they have experienced since FMT
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 |
What the registry record for NCT05373784 still lists
NCT05373784 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 25,234-participant average among 8 other Diverticulitis trials with a reported enrollment target (100% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05373784's enrollment target sits among peer trials
10 9th of 8 the lowest of 8 other Diverticulitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diverticulitis 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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