Influence of Short-Term Antibiotic Therapy on Exercise

NCT05961189 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: Pro2023000127
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Gastrointestinal Microbiome; Exercise

Outcome Measures

Primary Outcomes (4)

• Maximal Oxygen Uptake

  Maximal oxygen consumption treadmill test to determine overall aerobic fitness

  one week

• Changes in gut microbiota

  Fecal assessment of gut microbiota (bacteria) to determine the effects of the antibiotic on gut bacteria.

  one week

• Metabolomics

  serum and fecal metabolomic measurements (positive and negative polar measurements to determine amino acid and carbohydrate alterations to metabolism. High performance liquid chromatography will be used to determine these levels in both feces and serum.

  one week

• Time Trial

  Treadmill based procedure to assess level of fitness (24-minutes of exercise: 8 minutes at 5.0 mph, 8 minutes at 6.0 mph, and 8 minutes at 7.0 mph followed by jog/run a distance equivalent to 5-km (\~3 miles) as quickly as possible, on the treadmill).

  one week

Secondary Outcomes (1)

• Serum blood measurments

  one week

Other Outcomes (3)

• Diet assessment

  one week

• Anthropometrics

  one week

• Body composition

  one week

Study Arms (1)

Antibiotics and exercise

EXPERIMENTAL

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.

Drug: Azithromycin

Interventions

Azithromycin DRUG

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

Also known as: Placebo

Antibiotics and exercise

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Colorado State University: collaborator

Study Sites (2)

Human Performance Clinical Research Lab

Fort Collins, Colorado, 80521, United States

RECRUITING

Nutrition, and Exercise Metabolism Lab

New Brunswick, New Jersey, 08901, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Sara C Campbell, PhD

  Rutgers, The State University of New Jersry

  PRINCIPAL INVESTIGATOR

• Christopher Bell, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara C Campbell, PhD

CONTACT

850 443 3843; saracamp@kines.rutgers.edu

Daniel D DeSio, MS

CONTACT

732 278 9116; ddd81@scarletmail.rutgers.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study will be a pre- post-testing study seeing if antibiotic administration (azithromycin) impacts the ability to exercise.

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: July 27, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the data.

Locations

US (2)