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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to, during, after antibiotic course
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine whether antibiotic-induced perturbation of the microbiome has measurable metabolic and immunologic effects during and after the treatment period.
Secondary outcome measures
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.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group CExperimental Treatment1 Intervention
Azithromycin
Group II: Group BExperimental Treatment1 Intervention
Amoxicillin
Group III: Group AExperimental Treatment1 Intervention
Control
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amoxicillin
2017
Completed Phase 4
~7780
Azithromycin
2018
Completed Phase 4
~274950

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,259 Total Patients Enrolled
Christa S Zerbe, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
7 Previous Clinical Trials
402 Total Patients Enrolled

Media Library

Amoxicillin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT02707042 — Phase 1
Healthy Subjects Research Study Groups: Group C, Group B, Group A
Healthy Subjects Clinical Trial 2023: Amoxicillin Highlights & Side Effects. Trial Name: NCT02707042 — Phase 1
Amoxicillin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02707042 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the qualifications for participation in this clinical experiment?

"This clinical trial seeks 210 individuals between the ages of 18-49 with normal physiological conditions. To qualify, participants must be not yet have reached their 50th birthday and willing to contribute biological samples for storage; furthermore, they are required to comply with study procedures and consume capsules as directed."

Answered by AI

Is this research endeavor currently recruiting participants?

"This research trial is currently open for registration, as stated on clinicaltrials.gov. It was initially made available to the public on March 22nd 2017 and last updated October 29th 2022."

Answered by AI

Does the FDA endorse this particular therapeutic approach?

"The safety of this treatment was estimated to be a 1 on the scale, as it is presently in Phase 1. This implies that there are limited data points supporting its efficacy and security."

Answered by AI

To what medical conditions has this form of therapy been known to be efficacious?

"This remedy is primarily utilized to battle genital ulcer disease (GUD) but can be applied to lower respiratory tract infection (LRTI), Chlamydia, and other ailments among adult patients."

Answered by AI

What is the current size of participation for this clinical trial?

"Affirmative. Clinicaltrials.gov records reveal that this medical trial, which was initially posted on March 22nd 2017, is actively looking for participants. 210 individuals need to be recruited from two different research facilities."

Answered by AI

Does this experiment involve any participants that are 25 years or older?

"The requirements for this trial necessitate that all participants are between 18 and 49; 94 experiments exist specifically to accommodate those below the age of majority, while 454 studies are available to seniors."

Answered by AI
~14 spots leftby Nov 2024