A Phase 4 interventional study of Amoxicillin Oral Capsule in Antibiotic Enterocolitis, sponsored by Rockefeller University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Rockefeller University · Phase 4, Interventional, and Basic science
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.
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.
43 studies on the registry are indexed under Enterocolitis, Pseudomembranous; 5 are open to participants now.
This study's enrollment of 10 is below the median of 100 across 29 interventional studies indexed under Enterocolitis, Pseudomembranous.
Browse Enterocolitis, Pseudomembranous studies →Rockefeller University is the lead sponsor of 123 studies on the registry; 3 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy controls
Drug: Amoxicillin Oral Capsule
Amoxicillin 875mg every 12 hours for 7 days.
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.
Time frame: 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.
Time frame: 7 days
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.
Time frame: 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.
Time frame: 7 days
Healthy volunteers were recruited from the general public and the University's research volunteer repository. The first participant was screened on June 23, 2023 and accrual was completed on August 4 2023.
| Milestone | Healthy Controls |
|---|---|
| Started | 10 |
| Completed | 9 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
Change in the mean number of colonic submucosal neurons counted per mm\^2 (+/- standard deviation) after antibiotics treatment compared to pre-treatment baseline.
| neuronal cells/mm^2 | Healthy Controls |
|---|---|
| Change in Mean Number of Colonic Submucosal Neurons/mm^2 in the Colon After Antibiotic Treatment | 0 ± 0 |
Change in mean number of colonic submucosal glia counted per mm\^2 (+/- standard deviation) after antibiotics treatment compared to pretreatment baseline.
| cells/mm^2 | Healthy Controls |
|---|---|
| Change in Mean Number of Colonic Submucosal Glia/mm^2 in the Colon After Treatment With Antibiotics | 127.89 ± 151.8 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over mean 62 days; Adverse event data were collected for each participant from the time of enrollment until after all procedures were completed and participant went off study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Controls | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Healthy Controls |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 2 |
| Age, Continuous(years) | Healthy Controls |
|---|---|
| Mean | 57 ± 11 |
| Sex: Female, Male(Participants) | Healthy Controls |
|---|---|
| Female | 3 |
| Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | Healthy Controls |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 9 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Healthy Controls |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Healthy Controls |
|---|---|
| United States | 9 |
| Mean number of colonic neurons counted / mm^2 (+/- standard deviation)(cells/mm^2) | Healthy Controls |
|---|---|
| Mean | 0 ± 0 |
| Mean number of glial cells counted/mm^2 (+/- standard deviation)(cells/mm^2) | Healthy Controls |
|---|---|
| Mean | 661.39 ± 149.69 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Amoxicillin
Enterocolitis, Pseudomembranous →