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Antibiotic

Antibiotics Impact on Healthy Subjects

Phase 1

Recruiting

Led By Christa S Zerbe, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

Specific skin conditions at screening visit

Inability to complete required study visits

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to, during, after antibiotic course

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of two commonly used antibiotics on the human microbiome and on metabolic and immune physiology.

Who is the study for?

Healthy adults aged 18-50 who can swallow capsules and comply with study procedures. Participants must be willing to allow storage of their biological samples but cannot have used certain medications or substances in the past months, including systemic antibiotics, steroids, probiotics, antacids, laxatives, and more. Smokers and those with a range of health conditions or recent significant weight changes are excluded.

What is being tested?

The MIME Study is testing how two common antibiotics—amoxicillin and azithromycin—affect the human microbiome as well as metabolic and immune physiology in healthy volunteers. It's a randomized controlled trial where one group receives amoxicillin for 7 days, another azithromycin for 5 days, while a control group gets no drug intervention.

What are the potential side effects?

Potential side effects from taking amoxicillin or azithromycin may include digestive disturbances like diarrhea or nausea; allergic reactions such as skin rashes; potential yeast infections due to disruption of normal microbial flora; and less commonly fatigue or dizziness.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have certain skin conditions.

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I cannot attend all the required study visits.

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I experience loss of bladder control.

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My BMI is either above 35 or below 18.

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I have recently used certain medications or medical devices.

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I do not have any current infections or illnesses.

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I have had surgery on my digestive system.

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I have a weakened immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to, during, after antibiotic course

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to, during, after antibiotic course

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to, during, after antibiotic course for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine whether antibiotic-induced perturbation of the microbiome has measurable metabolic and immunologic effects during and after the treatment period.

Secondary study objectives

Changes in blood, cutaneous, intestinal, oral, salivary, urinary, vaginal bacterial microbiomes;

Changes in parameters of immune function and response in samples of blood, serum/plasma;

Changes in parameters of metabolic functioning, including measures of hormones relevant to metabolism.