Antibiotic EnterocolitisPhase 4NCT05834036
Effect of Antibiotics on Enteric Neurons and Glia
A Phase 4 study testing Amoxicillin Oral Capsule in people with Antibiotic Enterocolitis, run by Rockefeller University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Antibiotic Enterocolitis
- What is being tested?
- Amoxicillin Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2023to 9 Nov 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-75 years old of different sex and races.
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Antibiotics on Submucosal Enteric Neurons and Glia in the Lower Gastrointestinal
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.
Read the detailed description
The enteric nervous system (ENS) has been recognized as the "second brain" as it can regulate enteric physiology without central nervous system input. Similar to the central nervous system, it is composed of multiple neuron populations whose main functions are gut motility, secretion, and absorption. In addition to the neurons, the ENS contains glia cells whose main role is neuroprotection but also contribute to normal gut motility. Several studies have demonstrated that the microbiota and the ENS have an intimate relationship that begins in utero, and it is critical for its normal development. Neurons can recognize bacteria and their products. Several investigators have shown neuronal loss after enteric infections and antibiotic (Ampicillin) treatment in the muscularis layer, that results in delayed transit time in animal models. Hence, communication between the microbiota and the ENS is important to maintain normal gut motility. Disorders of Gut-Brain Interactions (DGBIs) are quite common, among these are Irritable Bowel Syndrome (IBS) defined by Rome IV criteria as abdominal pain associated with a change in consistency and frequency of bowel movements and the constipation predominant subtype (less than 3 bowel movements per week) is the most prevalent, which is also the most common motility disorder that mouse models of infection and antibiotics treatment exhibit. IBS has been associated with dysbiosis and a recent study demonstrated that antibiotic use immediately before or after screening colonoscopy increased the risk of developing IBS. In addition, dysfunction of submucosal neurons in IBS has been previously reported but whether there are changes in neuron numbers or neuron characteristics has not been explored. While there have been prospective studies that have explored the effects of antibiotics in patients treated for Helicobacter Pylori, there have been other investigators who have focused on the long term effects of antibiotics in healthy volunteers.
Therefore, similar to animal models, investigators propose that humans experience a profound and transient loss/alteration of neurons in the setting of antimicrobial use associated dysbiosis that manifest as DGBIs, most notably the constipation subtypes. This proposal will address whether antimicrobial use leads to quantitative and qualitative changes in the populations of submucosal neurons and glia cells in human subjects.
This hypothesis will be tested in a prospective study in which healthy participants will be asked to take the commonly used antibiotic amoxicillin twice a day for 7 days, and colon tissue biopsies will be obtained before and after treatment. Human tissue will be processed and analyzed to visualize structural changes, and changes in gene expression, bacteria, metabolites will be determined through single nuclei RNA sequencing, 16S ribosomal bacteria RNA sequencing and metabolomics analysis respectively.
- Conditions
- Antibiotic Enterocolitis
- Being tested
- Amoxicillin Oral Capsule
- Keywords
- Glia, Enteric Neurons
- Medical subject headings
- Enterocolitis, Pseudomembranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin Oral CapsuleDrug
Amoxicillin 875mg every 12 hours for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Experimental | Healthy controls Receives: Drug: Amoxicillin Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Number of Colonic Submucosal Neurons/mm^2 in the Colon After Antibiotic Treatment
Change in the mean number of colonic submucosal neurons counted per mm^2 (+/- standard deviation) after antibiotics treatment compared to pre-treatment baseline.
Measured: 7 days
Change in Mean Number of Colonic Submucosal Glia/mm^2 in the Colon After Treatment With Antibiotics
Change in mean number of colonic submucosal glia counted per mm^2 (+/- standard deviation) after antibiotics treatment compared to pretreatment baseline.
Measured: 7 days
Secondary outcomes (2)
Changes in Gene Expression in Submucosal Neurons
Neurons nuclei will be isolated, and RNA will be sequenced and identified through alignment to human genome. The amount of RNA will be normalized as transcripts per million (TPM unit) and fold changes of a transcript will be calculated by dividing the TPM numbers of a transcript before and after antibiotics treatment.
Measured: 7 days
Changes in Gene Expression in Submucosal Glia
Glia nuclei will be isolated, and RNA will be sequenced and identified through alignment to human genome. The amount of RNA will be normalized as transcripts per million (TPM unit) and fold changes of a transcript will be calculated by dividing the TPM numbers of a transcript before and after antibiotics treatment.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start23 Jun 2023
- Primary completion9 Nov 2023
- Study completion9 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Antibiotic EnterocolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Begum Aydin, PhD, Principal investigator, Rockefeller UniversityYelina Alvarez, MD/PhD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834036
- Sponsor's protocol ID
- YAL-1038
- Status last verified
- Feb 2026
- First submitted
- 14 Apr 2023
- Last updated
- 12 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antibiotics on Submucosal Enteric Neurons and Glia in the Lower Gastrointestinal
- ClinicalTrials.gov ID
- NCT05834036
- Acronym / sponsor ID
- YAL-1038
- Conditions
- Antibiotic Enterocolitis
- Keywords
- Glia, Enteric Neurons
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 9 Nov 2023 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Posted 12 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The enteric nervous system (ENS) has been recognized as the "second brain" as it can regulate enteric physiology without central nervous system input. Similar to the central nervous system, it is composed of multiple neuron populations whose main functions are gut motility, secretion, and absorption. In addition to the neurons, the ENS contains glia cells whose main role is neuroprotection but also contribute to normal gut motility. Several studies have demonstrated that the microbiota and the ENS have an intimate relationship that begins in utero, and it is critical for its normal development. Neurons can recognize bacteria and their products. Several investigators have shown neuronal loss after enteric infections and antibiotic (Ampicillin) treatment in the muscularis layer, that results in delayed transit time in animal models. Hence, communication between the microbiota and the ENS is important to maintain normal gut motility. Disorders of Gut-Brain Interactions (DGBIs) are quite common, among these are Irritable Bowel Syndrome (IBS) defined by Rome IV criteria as abdominal pain associated with a change in consistency and frequency of bowel movements and the constipation predominant subtype (less than 3 bowel movements per week) is the most prevalent, which is also the most common motility disorder that mouse models of infection and antibiotics treatment exhibit. IBS has been associated with dysbiosis and a recent study demonstrated that antibiotic use immediately before or after screening colonoscopy increased the risk of developing IBS. In addition, dysfunction of submucosal neurons in IBS has been previously reported but whether there are changes in neuron numbers or neuron characteristics has not been explored. While there have been prospective studies that have explored the effects of antibiotics in patients treated for Helicobacter Pylori, there have been other investigators who have focused on the long term effects of antibiotics in healthy volunteers.
Therefore, similar to animal models, investigators propose that humans experience a profound and transient loss/alteration of neurons in the setting of antimicrobial use associated dysbiosis that manifest as DGBIs, most notably the constipation subtypes. This proposal will address whether antimicrobial use leads to quantitative and qualitative changes in the populations of submucosal neurons and glia cells in human subjects.
This hypothesis will be tested in a prospective study in which healthy participants will be asked to take the commonly used antibiotic amoxicillin twice a day for 7 days, and colon tissue biopsies will be obtained before and after treatment. Human tissue will be processed and analyzed to visualize structural changes, and changes in gene expression, bacteria, metabolites will be determined through single nuclei RNA sequencing, 16S ribosomal bacteria RNA sequencing and metabolomics analysis respectively.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Experimental | Drug: Amoxicillin Oral CapsuleHealthy controls |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-75 years old of different sex and races.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxicillin Oral CapsuleAmoxicillin 875mg every 12 hours for 7 days. | Drug | Healthy Controls |
Primary outcome
Change in Mean Number of Colonic Submucosal Neurons/mm^2 in the Colon After Antibiotic Treatment
Time frame: 7 days
Change in the mean number of colonic submucosal neurons counted per mm^2 (+/- standard deviation) after antibiotics treatment compared to pre-treatment baseline.
Change in Mean Number of Colonic Submucosal Glia/mm^2 in the Colon After Treatment With Antibiotics
Time frame: 7 days
Change in mean number of colonic submucosal glia counted per mm^2 (+/- standard deviation) after antibiotics treatment compared to pretreatment baseline.
2 secondary outcomes
Changes in Gene Expression in Submucosal Neurons
Time frame: 7 days
Changes in Gene Expression in Submucosal Glia
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Antibiotic Enterocolitis
Active, not recruitingObservational study
REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs
Dysbiosis, Clostridium Difficile
Active, not recruitingObservational study
Antibiotic Exposure on Gut Microbiota and Motility Establishment in Newborns
NEC - Necrotizing Enterocolitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Begum Aydin, PhD principal investigator
Rockefeller University
Yelina Alvarez, MD/PhD principal investigator
Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxicillin Oral Capsule in people with Antibiotic Enterocolitis, run by Rockefeller University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Number of Colonic Submucosal Neurons/mm^2 in the Colon After Antibiotic Treatment (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.