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Completed

NCT Number: NCT05515562

Effects of Intravenous (IV) Omadacycline on Gut Microbiome

Given the clinical need to improve upon current antibiotic regimens for the treatment of C. difficile infection with a particular focus on the impact of therapies on gut microbiome, this study proposes to characterize the impact of Intravenous (IV) omadacycline on gut microbiome of healthy volunteers.

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Key information

Conditions

Microbial Colonization Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

About this study

The plan to enroll eight healthy volunteers between the ages of 18 and 40 years and without history of cardiovascular, gastrointestinal, hepatic, or renal disease to receive 5 days of intravenous omadacycline followed by 5 days of oral omadacycline. Stool and saliva samples will be collected at pre-specified times and analyzed to characterize the impact of IV omadacycline on gut microbiome.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-40 years of age
  • Willing and able to comply with all study procedures
  • Considered healthy without history of cardiovascular, gastrointestinal, hepatic, or renal disease
  • males or females - females of child bearing potential must agree to use a highly effective contraception during the study and for at least 7 days after the last dose of omadacycline

Exclusion criteria

  • Consumed probiotics within 30 days before enrollment
  • Consumed antibiotics within 90 days prior to enrollment
  • Known hypersensitivity to omadacycline or tetracycline-class antibiotics
  • pregnant or breastfeeding
  • in the opinion of the investigator is experiencing signs or symptoms of acute illness that increase the risk of adverse effects from participating in the study
  • previously participated in the study

Treatment and study plan

Omadacycline Injection

Drug

All participants will receive Intravenous (IV) omadacycline

Other names: Omadacycline oral

Primary outcomes

  1. Phylum Level Mean Proportional Relative Abundance

    Time frame: Day 30

    In general, the healthy volunteer analyses will assess changes in total and species-specific microbiota over time as well as changes in microbial diversity.

  2. Phylum Level Mean Proportional Relative Abundance

    Time frame: Baseline

    In general, the healthy volunteer analyses will assess changes in total and species-specific microbiota over time as well as changes in microbial diversity.

  3. Phylum Level Mean Proportional Relative Abundance

    Time frame: Day 5

    In general, the healthy volunteer analyses will assess changes in total and species-specific microbiota over time as well as changes in microbial diversity.

  4. Phylum Level Mean Proportional Relative Abundance

    Time frame: Day 10

    In general, the healthy volunteer analyses will assess changes in total and species-specific microbiota over time as well as changes in microbial diversity.

  5. Bacterial DNA Per Gram of Stool

    Time frame: Baseline

    nanograms (ng) per gram of stool for bacterial DNA

  6. Bacterial DNA Per Gram of Stool

    Time frame: During Therapy up to Day 6

    nanograms (ng) per gram of stool for bacterial DNA

  7. Bacterial DNA Per Gram of Stool

    Time frame: End of Therapy up to Day 10

    nanograms (ng) per gram of stool for bacterial DNA

  8. Order Level Mean Proportional Relative Abundance

    Time frame: Baseline

    Order Level Mean Proportional Relative Abundance - Relative abundance % for order

  9. Order Level Mean Proportional Relative Abundance

    Time frame: Day 5

    Order Level Mean Proportional Relative Abundance - Relative abundance % for order

  10. Order Level Mean Proportional Relative Abundance

    Time frame: Day 10

    Order Level Mean Proportional Relative Abundance - Relative abundance % for order

  11. Order Level Mean Proportional Relative Abundance

    Time frame: Day 30

    Order Level Mean Proportional Relative Abundance - Relative abundance % for order

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • High Point University
  • Paratek Pharmaceuticals Inc
  • University of Houston

Registry information

Official study title

Effects of IV Omadacycline on Gut Microbiome

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 25, 2022
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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