Your session is about to expire
← Back to Search
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ one week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one week
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 moreSecondary outcome measures
Serum blood measurments
Other outcome measures
Anthropometrics
Body composition
Diet assessment
Side effects data
From 2018 Phase 4 trial • 190238 Patients • NCT020479813%
Death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Biannual Mass Oral Azithromycin
Biannual Mass Oral Placebo
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
430 Previous Clinical Trials
64,618 Total Patients Enrolled
Colorado State UniversityOTHER
127 Previous Clinical Trials
38,399 Total Patients Enrolled
Sara C Campbell, PhDPrincipal InvestigatorRutgers, The State University of New Jersry
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of heart or blood vessel diseases, high blood pressure, stroke, heart murmur, sickle cell anemia, or lung problems.I have taken antibiotics or probiotics in the last 3 months.I was diagnosed with pneumonia in the last 6 months.I identify as either male or female.I am between 18 and 40 years old.I use hormonal birth control methods.I had liver problems or jaundice from taking azithromycin before.
Research Study Groups:
This trial has the following groups:- Group 1: Antibiotics and exercise
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger