Understanding how E. coli behaves in the human gut
Study of the Ecological and Evolutionary Dynamics of Escherichia Coli in the Digestive Commensal Flora
This study is trying to see how E. coli bacteria behave and change in the guts of healthy people to better understand its role in health and disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT05153824 on ClinicalTrials.gov |
What this trial studies
This study investigates the ecological and evolutionary dynamics of Escherichia coli within the digestive system of healthy individuals. It aims to quantify the changes in E. coli strains in the gut microbiota, focusing on how these changes are influenced by both host and bacterial characteristics. By studying a large population of healthy volunteers, the research seeks to shed light on the colonization dynamics of E. coli, which is crucial for understanding its role in antibiotic resistance and virulence. The study will also explore the intra-host evolution of E. coli over time.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 65 with normal gastrointestinal function.
Not a fit: Patients with chronic gastrointestinal illnesses or known immunosuppression are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved strategies for managing E. coli infections and antibiotic resistance.
How similar studies have performed: While studies on gut microbiota exist, this specific focus on E. coli dynamics in healthy individuals is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * healthy volunteer of both sexes between the ages of 18 and 65 years old included * subject considered healthy after a thorough general examination (interrogation, physical examination) * subject with normal transit with usually one molded saddle per day * BMI between 18.5 and 35 kg / m² included Exclusion Criteria: * Subject living in an institution * Known immunosuppression (HIV, concomitant immunosuppressive therapy, chemotherapy, long-term corticosteroids regardless of the dose\> 2 weeks in the last 6 months) * Chronic gastrointestinal illness (Chronic Hemorrhagic Recto-colitis, Crohn's Disease) * Any digestive resection except appendectomy and resection of polyps * Subject with a history (s) of bacteremia * Subject protected by law under guardianship or curator-ship * Pregnant or lactating woman * Subject deprived of liberty under judicial duress * Lack of affiliation to a social security scheme * Patient on State Medical Aid * Absence of signed consent before entering the study
Where this trial is running
Paris and 1 other locations
- Bichat Claude Bernard Hospital — Paris, France (Recruiting)
- Bichat Hospital, Clinical Investigation Center — Paris, France (Recruiting)
Study contacts
- Study coordinator: Xavier M DUVAL, MD, PhD
- Email: xavier.duval@aphp.fr
- Phone: +33 (0)1 40 25 71 48
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.