CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 10 enrolled
Drug / intervention
Amoxicillin Oral Capsuledrug
Likely dose
Amoxicillin Oral Capsule 875mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05834036
NCT05834036Phase 4Completed

Effect of Antibiotics on Submucosal Enteric Neurons and Glia in the Lower Gastrointestinal

Rockefeller University·interventional·Posted Apr 28, 2023·Updated Mar 12, 2026

In Brief

A Phase 4 clinical trial evaluating Amoxicillin Oral Capsule for Antibiotic Enterocolitis. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
202420252026
First PostedApr 28, 2023
Enrollment StartJun 23, 2023
Primary CompletionNov 9, 2023
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 3.2 years ago

Interventions

Amoxicillin Oral Capsuledrug

Amoxicillin 875mg every 12 hours for 7 days.