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Azithromycin Impact on Exercise Performance

Phase < 1
Recruiting
Led By Sara C Campbell, PhD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one week
Awards & highlights

Study Summary

This trial will study how a 5-day antibiotic treatment affects exercise performance in healthy adults.

Who is the study for?
This trial is for healthy adults aged 18-40 who exercise regularly (at least 150 minutes of moderate-to-vigorous activity per week) and can run on a treadmill for an hour. Women must use hormonal contraception. People with recent antibiotic or probiotic use, drug hypersensitivity, certain health conditions, or pregnancy are excluded.Check my eligibility
What is being tested?
The study tests the effect of a short-term course of Azithromycin, an antibiotic, on exercise performance in young adults. Participants will be randomly assigned to receive either Azithromycin or a placebo for five days and their treadmill performance will be compared before and after treatment.See study design
What are the potential side effects?
Azithromycin may cause side effects like digestive issues (nausea, diarrhea), potential liver problems (jaundice), allergic reactions in those sensitive to similar drugs, and could affect gut bacteria balance which is being studied in relation to exercise.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one week
This trial's timeline: 3 weeks for screening, Varies for treatment, and one week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in gut microbiota
Maximal Oxygen Uptake
Metabolomics
+1 more
Secondary outcome measures
Serum blood measurments
Other outcome measures
Anthropometrics
Body composition
Diet assessment

Side effects data

From 2018 Phase 4 trial • 190238 Patients • NCT02047981
3%
Death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Biannual Mass Oral Placebo
Biannual Mass Oral Azithromycin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Antibiotics and exerciseExperimental Treatment1 Intervention
Participants will be tested before and after 5 days of azithromycin, per manufacturer's instructions, to determine if that impacts exercise performance and the gut microbiome and gut/serum metabolome.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azithromycin
2018
Completed Phase 4
~274950

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,192 Total Patients Enrolled
Colorado State UniversityOTHER
125 Previous Clinical Trials
38,319 Total Patients Enrolled
Sara C Campbell, PhDPrincipal InvestigatorRutgers, The State University of New Jersry

Media Library

Antibiotics and exercise Clinical Trial Eligibility Overview. Trial Name: NCT05961189 — Phase < 1
Gastrointestinal Microbiome Research Study Groups: Antibiotics and exercise
Gastrointestinal Microbiome Clinical Trial 2023: Antibiotics and exercise Highlights & Side Effects. Trial Name: NCT05961189 — Phase < 1
Antibiotics and exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT05961189 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom is this therapeutic research accessible?

"In order to qualify, potential participants must have a healthy gastrointestinal microbiome and be within the 18-40 age range. The total number of accepted applicants is 40."

Answered by AI

Is eligibility for this research project restricted to a certain age bracket?

"Patients aged 18-40 are eligible for this clinical trial. For those younger or older, there 14 studies available for minors and 65 studies accessible to seniors."

Answered by AI

Are volunteers being welcomed to partake in this research endeavor?

"As per information on clinicaltrials.gov, applications for this medical trial are not being accepted at the moment; though it was initially posted in September 1st 2023 and last edited on July 17th 2023. Fortunately, 104 other studies require participants now."

Answered by AI
~20 spots leftby Jan 2025