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NCT05834036 · ClinicalTrials.gov registry record · Phase 4
Effect of Antibiotics on Enteric Neurons and Glia
A Phase 4 study of Antibiotic Enterocolitis, sponsored by Rockefeller University.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05834036: Completed Phase 4 study of Antibiotic Enterocolitis, sponsored by Rockefeller University.
NCT05834036 is a Phase 4 study of Antibiotic Enterocolitis that has completed, run by Rockefeller University. The registered enrollment target is 10 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05834036, a Phase 4 study of Antibiotic Enterocolitis, has completed, sponsored by Rockefeller University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The interactions between bacteria and their products with the intestinal tissue are important for maintaining a healthy and balanced system. Alterations in gut bacteria communities have been associated with various human pathologies. The investigators have found that mice treated with short and long-term antibiotics exhibit a transient yet profound loss of neurons in the more superficial submucosal and deeper muscularis plexi in the intestine accompanied by slow motility. Glia cells also depend on microbiota for their maintenance. In humans, antibiotic use has been associated with disorders of gut-brain interactions (DGBI) such as irritable bowel syndrome however whether there are changes in the enteric neurons and glia cells remain unknown. Therefore, the investigators propose to further characterize the neurons and glia populations in the human distal colon after a single antibiotic course. This study will reveal glia and neuronal subtypes that are susceptible to changes in the bacteria populations and depend on microbial products for their maintenance. These findings will guide future DGBI studies to ascertain the physiological effects that such loss has on intestinal healthy balance.
Primary Outcome
Change in the mean number of colonic submucosal neurons counted per mm\^2 (+/- standard deviation) after antibiotics treatment compared to pre-treatment baseline.
Conditions Studied
Interventions
- DRUG Amoxicillin Oral Capsule
Study Locations (1)
New York
- Rockefeller University - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-06-23 |
| Est. Completion | 2023-11-09 |
| Phase | Phase 4 |
What the finished NCT05834036 record still lists
NCT05834036 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 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Antibiotic Enterocolitis appearing as the primary indexed condition, and to 1 intervention - of which Amoxicillin Oral Capsule is the first listed.
NCT05834036 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05834036 about?
NCT05834036 is a clinical study titled "Effect of Antibiotics on Enteric Neurons and Glia". The interactions between bacteria and their products with the intestinal tissue are important for maintaining a healthy and balanced system. Alterations in gut bacteria communities have been associated with various human pathologies. The investigators have found that mice treated with short and long...
What is the current status of trial NCT05834036?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2023-06-23. Estimated completion is 2023-11-09.
What conditions does trial NCT05834036 study?
This clinical trial studies the following conditions: Antibiotic Enterocolitis.
What interventions are being tested in trial NCT05834036?
The interventions under investigation include: Amoxicillin Oral Capsule (DRUG).
Who is sponsoring clinical trial NCT05834036?
This trial is sponsored by Rockefeller University, which has 117 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05834036 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 NCT05834036's enrollment target sits among peer trials
10 1940th of 2000 higher than 33 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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