CompletedPhase 4

Effect of Antibiotics on Enteric Neurons and Glia

United States10 participantsStarted 2023-06-23

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. * …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Mean Number of Colonic Submucosal Neurons/mm^2 in the Colon After Antibiotic Treatment

Timeframe: 7 days

Change in Mean Number of Colonic Submucosal Glia/mm^2 in the Colon After Treatment With Antibiotics

Timeframe: 7 days

Trial details

NCT IDNCT05834036

SponsorRockefeller University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-09

Results submitted2025-07-24

View on ClinicalTrials.gov More Antibiotic Enterocolitis trials