Trial Outcomes & Findings for Effect of Antibiotics on Enteric Neurons and Glia (NCT NCT05834036)

Last Updated: 2026-03-12

Results Overview

Change in the mean number of colonic submucosal neurons counted per mm\^2 (+/- standard deviation) after antibiotics treatment compared to pre-treatment baseline.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

7 days

Results posted on

2026-03-12

Participant Flow

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.

There were no preassignment events of significance. Of the 10 participants consented, one withdrew from the study before the first study procedure.

Participant milestones

Participant milestones
Measure	Healthy Controls Healthy controls Amoxicillin Oral Capsule: Amoxicillin 875mg every 12 hours for 7 days.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Healthy Controls Healthy controls Amoxicillin Oral Capsule: Amoxicillin 875mg every 12 hours for 7 days.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

From the analysis of a minimum of 5 histological sections, from each of 6 mucosal biopsy samples collected from 5 of the enrolled participants, there was no detectable signal using the Hu antigen C and Hu antigen D (HuC/D) neuronal cell body marker to indicate the presence of neuronal cell bodies in the tissues. This result indicates that there were no detectable neurons in the samples analyzed.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Controls n=9 Participants Healthy controls Amoxicillin Oral Capsule: Amoxicillin 875mg every 12 hours for 7 days.
Age, Categorical <=18 years	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=9 Participants
Age, Categorical >=65 years	2 Participants n=9 Participants
Age, Continuous	57 years STANDARD_DEVIATION 11 • n=9 Participants
Sex: Female, Male Female	3 Participants n=9 Participants
Sex: Female, Male Male	6 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	6 Participants n=9 Participants
Race (NIH/OMB) White	3 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants
Region of Enrollment United States	9 participants n=9 Participants
Mean number of colonic neurons counted / mm^2 (+/- standard deviation)	0 cells/mm^2 STANDARD_DEVIATION 0 • n=5 Participants • From the analysis of a minimum of 5 histological sections, from each of 6 mucosal biopsy samples collected from 5 of the enrolled participants, there was no detectable signal using the Hu antigen C and Hu antigen D (HuC/D) neuronal cell body marker to indicate the presence of neuronal cell bodies in the tissues. This result indicates that there were no detectable neurons in the samples analyzed.
Mean number of glial cells counted/mm^2 (+/- standard deviation)	661.39 cells/mm^2 STANDARD_DEVIATION 149.69 • n=5 Participants • From the analysis of a minimum of 5 histological sections, from each of 6 mucosal biopsy samples collected from 5 of the enrolled participants, there was detectable signal from Sex Determining Region Y Box Transcription Factor 10 (SOX10) glial marker to indicate the presence of glial cells in the tissues.

PRIMARY outcome

Timeframe: 7 days

Population: From the analysis of a minimum of 5 histological sections, from each of 6 mucosal biopsy samples collected from 5 of the enrolled participants after amoxicillin treatment, there was no detectable HuC/D (neuronal cell body marker) signal to indicate the presence of neuronal cell bodies in the tissues. There was no change in the number of neurons detectable.

Change in the mean number of colonic submucosal neurons counted per mm\^2 (+/- standard deviation) after antibiotics treatment compared to pre-treatment baseline.

Outcome measures

Outcome measures
Measure	Healthy Controls n=5 Participants Healthy controls 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	0 neuronal cells/mm^2 Standard Deviation 0

PRIMARY outcome

Timeframe: 7 days

Population: From the analysis of a minimum of 5 histological sections, from each of 6 mucosal biopsy samples collected from 5 of the enrolled participants after treatment with amoxicillin, there was detectable signal using SOX10 (glial marker) to indicate the presence of glial cell in the tissues.

Change in mean number of colonic submucosal glia counted per mm\^2 (+/- standard deviation) after antibiotics treatment compared to pretreatment baseline.

Outcome measures

Outcome measures
Measure	Healthy Controls n=5 Participants Healthy controls Amoxicillin Oral Capsule: Amoxicillin 875mg every 12 hours for 7 days.
Change in Mean Number of Colonic Submucosal Glia/mm^2 in the Colon After Treatment With Antibiotics	127.89 cells/mm^2 Standard Deviation 151.8

SECONDARY outcome

Timeframe: 7 days

Population: Outcome Measure 3 requires the presence of neurons in the tissue to carry out transcriptional profiling of neurons. The imaging analysis of the samples from Outcome Measure 1 revealed no detectable neurons in the collected samples. Therefore, it would be futile to carry out the analysis for Outcome Measure 3 where there were no neurons, and it was not performed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days

Population: Outcome Measure 4 , the transcriptional analysis of glial cells, requires the transcriptional analysis of neuron transcripts from Outcome Measure 3 for comparison. The imaging analysis of the samples from Outcome Measure 1 revealed no detectable neurons and therefore, the analysis for Outcome Measure 3 was not performed. In the absence of data from Outcome Measure 3, the transcriptional analysis of glia for Outcome Measure 4 was not performed.

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.

Outcome measures

Outcome data not reported

Adverse Events

Healthy Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Research Officer

The Rockefeller University Center for Clinical and Translational

Phone: 2123278408

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place