Phase 4
N=10
Effect of Antibiotics on Enteric Neurons and Glia
Antibiotic Enterocolitis
Bottom Line
View on ClinicalTrials.gov: NCT05834036 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Change in Mean Number of Colonic Submucosal Neurons/mm^2 in the Colon After Antibiotic Treatment — 0 neuronal cells/mm^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Amoxicillin Oral Capsule (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rockefeller University
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Number of Colonic Submucosal Neurons/mm^2 in the Colon After Antibiotic Treatment |
— | — |
| PRIMARY Change in Mean Number of Colonic Submucosal Glia/mm^2 in the Colon After Treatment With Antibiotics |
127.89 | — |
| SECONDARY Changes in Gene Expression in Submucosal Neurons |
— | — |
| SECONDARY Changes in Gene Expression in Submucosal Glia |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 18-75 years old of different sex and races.
Exclusion Criteria
- Allergy to penicillin, amoxicillin, augmentin, ampicillin, and other antibiotics in the penicillin family
- Pregnancy or fertility treatments
- Usage of antibiotics, antifungals or antivirals within three months prior to participation
- Change in dietary habits within the last three months prior to participation such as transitioning from high fat western diet to primarily plant based diet, initiation of ketogenic, paleo or any other weight loss regimen.
- Acute (in the past 30 days) or chronic enteric infections, including C. difficile.
- Chronic gastrointestinal disorder including inflammatory bowel disease, celiac disease , irritable bowel syndrome, chronic constipation or diarrhea
- Active neuropsychiatric disorder that requires anti-psychotic ie typical and atypical antipsychotics as well as anti-epileptics, levodopa, rivastigmine or any other neuropsychiatric medication with dopaminergic and cholinergic effects.
- Myocardial infarction or cerebrovascular accident in the six months prior to participation
- Coagulation disorders
- Chronic immunosuppressive medication (systemic) usage
- Anti-coagulation and anti-platelet agents such as plavix, warfarin, heparin, direct oral anticoagulants.
- Low dose Aspirin does not constitute an exclusion criteria.
- Prior episode of C. difficile infection.
- Prosthetic heart valves or any other conditions that require pre-procedure antibiotics.
- Currently receiving chemotherapy
- Any medical, psychological or social condition, in the opinion of the investigator, would jeopardize the health or well-being of the participant, interfere with their participation in the study, or confound the results of the study.
Data sourced from ClinicalTrials.gov (NCT05834036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.