Effects of Intravenous (IV) Omadacycline on Gut Microbiome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of IV Omadacycline on Gut Microbiome

Conditions
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Microbial Colonization

Intervention / Treatment
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* Drug: Omadacycline Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous (IV) Omadacycline<br>All participants will receive 5 days of IV omadacycline followed by 5 days of oral omadacycline | Drug: Omadacycline Injection<br>* All participants will receive Intravenous (IV) omadacycline<br>* Other names: Omadacycline oral;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gut microbiota concentrations | In general, the healthy volunteer analyses will assess changes in total and species-specific microbiota over time as well as changes in microbial diversity. | Day 31 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut Microbiome, Clostridioides difficile