Effects of short-term antibiotic use on exercise performance
Influence of Short-Term Antibiotic Therapy on Exercise
This study tests if taking the antibiotic azithromycin for 5 days affects how well young, healthy adults can exercise compared to a placebo.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 2 sites (Fort Collins, Colorado and 1 other locations) |
| Trial ID | NCT05961189 on ClinicalTrials.gov |
What this trial studies
This study investigates how a 5-day course of the antibiotic azithromycin affects exercise performance in young, healthy adults. Participants will be randomly assigned to receive either azithromycin or a placebo, and their treadmill exercise performance will be assessed before and after the treatment. Additionally, the study will analyze fecal samples to understand changes in the gut microbiome, along with measuring blood markers related to inflammation and gut health. The double-blind design ensures that neither participants nor researchers know who receives the antibiotic or placebo until the study concludes.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18-40 who engage in regular physical activity and can run for 60 minutes on a treadmill.
Not a fit: Patients who have recently used antibiotics or probiotics, are pregnant, or have certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how gut health influences exercise performance, potentially leading to new strategies for enhancing athletic performance.
How similar studies have performed: While animal studies have shown promising results regarding the gut microbiome's influence on exercise, this approach in humans is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 18-40 years of age Must identify as male or female Able and willing to run for 60 minutes on a treadmill without stopping Completed a minimum of150 minutes per week of moderate-to-vigorous physical activity over the previous year. For participants who were assigned female at birth (i.e., born as biological females), they must currently use hormonal methods of contraception. Exclusion Criteria: * Use of either antibiotics or probiotics within the previous 12-weeksCurrently pregnant, trying to become pregnant, or breastfeeding Identification of a contraindication to exercise Previous diagnosis of any of the following: heart disease, peripheral vascular disease, high blood pressure, stroke, a heart murmur, sickle cell anemia, or a pulmonary(breathing) disorder. Previous hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug. History of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. Diagnosis of pneumonia within previous 6-months.
Where this trial is running
Fort Collins, Colorado and 1 other locations
- Human Performance Clinical Research Lab — Fort Collins, Colorado, United States (Recruiting)
- Nutrition, and Exercise Metabolism Lab — New Brunswick, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Sara C Campbell, PhD — Rutgers, The State University of New Jersry
- Study coordinator: Sara C Campbell, PhD
- Email: saracamp@kines.rutgers.edu
- Phone: 850 443 3843
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.