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NCT05961189
Influence of Short-Term Antibiotic Therapy on Exercise
EARLY_PHASE1 trial testing Azithromycin in Gastrointestinal Microbiome in 40 participants. Currently enrolling.
1 December 2025
Quick facts
| Lead sponsor | Rutgers, The State University of New Jersey |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 40 |
| Start date | 1 September 2023 |
| Primary completion | 1 December 2025 |
| Estimated completion | 1 December 2025 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Azithromycin (azithromycin) — full drug profile →
Conditions studied
- Gastrointestinal Microbiome — all drugs for Gastrointestinal Microbiome →
- Exercise — all drugs for Exercise →
Sponsor
Rutgers, The State University of New Jersey
Who can join
Adults 18 to 40, any sex, with Gastrointestinal Microbiome or Exercise. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The gut microbiome refers to the trillions of bacteria that inhabit the stomach and other regions involved in the digestion of food, including the intestines. Compelling studies of animals (rodents) suggest that the health of the gut microbiome may influence skeletal muscle function and exercise performance. To date, there have been no similar observations reported in humans. A common experimental approach in animal studies to temporarily disrupt the gut microbiome is through the use of antibiotic therapies. Azithromycin is an antibiotic medicine prescribed to humans for the treatment of mild to moderate infections caused by bacteria. The purpose of the proposed project is to determine the influence of short-term (5-days) antibiotic therapy (azithromycin) on exercise performance in young, healthy adults. Treadmill exercise performance will be compared in two groups of adults before and after 5-days ingestion of azithromycin, or a placebo (something that has no physical effect).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05961189
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05961189 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rutgers, The State University of New Jersey
- Last refreshed: 24 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05961189.
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