Understanding how gut bacteria affect drug metabolism
Incorporating Drug Metabolism by the Human Gut Microbiome Into Personalized Medicine
This study is testing how gut bacteria affect how our bodies process certain medications to help improve treatment methods in the future.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 1 site (Somerville, New Jersey) |
| Trial ID | NCT05065671 on ClinicalTrials.gov |
What this trial studies
This study investigates how the human gut microbiome influences the metabolism of certain drugs by conducting single-dose pharmacokinetic studies in humans. The researchers aim to compare laboratory findings with clinical results to confirm the role of microbiome-derived metabolism (MDM) in drug processing. By establishing microbiome-dependent pharmacokinetic profiles, the study seeks to bridge the gap between preclinical and clinical research, ultimately leading to improved methodologies for incorporating MDM into clinical practice.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 65 with a body mass index between 18.5 and 29.9 kg/m2.
Not a fit: Patients with significant liver impairment, gastrointestinal diseases, or those on antibiotics in the past three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance personalized medicine by tailoring drug therapies based on individual microbiome profiles.
How similar studies have performed: While the concept of microbiome influence on drug metabolism is gaining attention, this specific approach is relatively novel and has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 to 65 years of age * Body mass index between 18.5 - 29.9 kg/m2 Exclusion Criteria * Estimated creatinine clearance \< 50 mL/min * Liver impairment (liver enzymes \> 2 times upper limit) * Antibiotics in the past 3 months * History of gastrointestinal disease * History of autoimmune disorder * Chronic viral infection * Smoker * Alcohol intake (defined as having up to 1 drink per day for women and up to 2 drinks per day for men) * Use of immune modulating medications * Diabetes mellitus * Any history or contraindication to the study medications * Additional exclusion criteria will be based on the FDA approved prescribing information for selected drugs (i.e., contraindications)
Where this trial is running
Somerville, New Jersey
- Robert Wood Johnson University Hospital Somerset — Somerville, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Luigi Brunetti, PhD
- Email: luigi.brunetti@rutgers.edu
- Phone: 908-595-2645
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.