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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 is a Phase 4 study of Antibiotic Enterocolitis that has completed, run by Rockefeller University. The registered enrollment target is 10 participants. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05834036
The ClinicalTrials.gov registry entry for NCT05834036 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rockefeller University, which has 117 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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