RecruitingEarly Phase 1NCT05961189

Influence of Short-Term Antibiotic Therapy on Exercise


Sponsor

Rutgers, The State University of New Jersey

Enrollment

40 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 YearsMax Age: 40 Years

Inclusion Criteria1

  • -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 Criteria1

  • 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.

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Interventions

DRUGAzithromycin

Standard of care, 5 days of drug per manufacturer's instructions.


Locations(2)

Human Performance Clinical Research Lab

Fort Collins, Colorado, United States

Nutrition, and Exercise Metabolism Lab

New Brunswick, New Jersey, United States

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NCT05961189


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