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Antibiotic
Amoxicillin for Antibiotic-Associated Diarrhea
Phase 4
Waitlist Available
Led By Yelina Alvarez, MD/PhD
Research Sponsored by Rockefeller University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group
Summary
This trial will study how taking the antibiotic amoxicillin for a short period affects gut nerve and support cells in healthy people. Researchers want to see if changes in gut bacteria from the antibiotic lead to conditions like irritable bowel syndrome. The findings could help understand how antibiotics impact gut health.
Eligible Conditions
- Antibiotic-Associated Diarrhea
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of colonic submucosal glia in the colon
Number of colonic submucosal neurons in the colon
Secondary study objectives
Changes in gene expression in submucosal glia
Changes in gene expression in submucosal neurons
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Healthy ControlsExperimental Treatment1 Intervention
Healthy controls
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amoxicillin Oral Capsule
2023
Completed Phase 4
~10
Find a Location
Who is running the clinical trial?
Rockefeller UniversityLead Sponsor
160 Previous Clinical Trials
16,517 Total Patients Enrolled
Yelina Alvarez, MD/PhDPrincipal InvestigatorRockefeller University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Taking a low dose of aspirin is not a reason to be excluded from the study.You have had a previous infection caused by C. difficile bacteria.You are currently undergoing chemotherapy treatment.You had a heart attack or stroke within the past six months.You recently changed your eating habits, like switching to a mostly plant-based diet or starting a weight loss program.You have a long-term digestive problem like inflammatory bowel disease, celiac disease, irritable bowel syndrome, chronic constipation, or chronic diarrhea.You have a mental health condition that requires certain medications like antipsychotics or medications for epilepsy, Parkinson's disease, or memory problems.You are pregnant or undergoing fertility treatments.You have used antibiotics, antifungals, or antiviral medications within the past three months.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Controls
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.