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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
No Placebo-Only Group

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.
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.
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

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

Side effects data

From 2022 Phase 4 trial • 42 Patients • NCT05027516
9%
pain at injection site
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rocephine®
Rocephine® + Azithromycin

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
455 Previous Clinical Trials
69,911 Total Patients Enrolled
Colorado State UniversityOTHER
133 Previous Clinical Trials
38,428 Total Patients Enrolled
Sara C Campbell, PhDPrincipal InvestigatorRutgers, The State University of New Jersry
Christopher Bell, PhDPrincipal InvestigatorColorado State University
3 Previous Clinical Trials
90 Total Patients Enrolled

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
~0 spots leftby Jan 2025
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