Effects of Intravenous (IV) Omadacycline on Gut Microbiome

Wake Forest University Health Sciences8 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Microbial Colonization

Interventions

Omadacycline InjectionDRUG

All participants will receive Intravenous (IV) omadacycline

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Phylum Level Mean Proportional Relative Abundance

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

Time frame: Day 30

Phylum Level Mean Proportional Relative Abundance

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

Time frame: Baseline

Phylum Level Mean Proportional Relative Abundance

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

Time frame: Day 5

Phylum Level Mean Proportional Relative Abundance

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

Time frame: Day 10

Bacterial DNA Per Gram of Stool

nanograms (ng) per gram of stool for bacterial DNA

Time frame: Baseline

Bacterial DNA Per Gram of Stool

nanograms (ng) per gram of stool for bacterial DNA

Time frame: During Therapy up to Day 6

Bacterial DNA Per Gram of Stool

nanograms (ng) per gram of stool for bacterial DNA

Time frame: End of Therapy up to Day 10

Order Level Mean Proportional Relative Abundance

Data from ClinicalTrials.gov

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