NCT05153824 Study of the Ecological and Evolutionary Dynamics of Escherichia Coli in the Digestive Commensal Flora
| NCT ID | NCT05153824 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Escherichia Coli; Infection, Intestinal |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-03-02 |
| Primary Completion | 2024-03-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2021-03-02 with a primary completion date of 2024-03-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Escherichia coli (E. coli) poses a major public health problem. E. coli is not only a commensal of the digestive tract but also a major opportunistic pathogen, first cause of urinary tract infections, first cause of bacteremia. However, little is known about the dynamics of intestinal colonization of the human host. Understanding the dynamics of colonization is crucial because selection for the major traits of E. coli is antibiotic resistance and virulence (the propensity to cause infection) works in commensalism, in the gut, not in infections. This study will make possible for the first time to study the colonization dynamics of E. coli in a large healthy host population. The main objective is to quantify the succession (gain, loss or replacement) of E. coli strains in the gut microbiota in healthy volunteers and how it depends on the properties of the host and the bacteria. This study will thus provide a better understanding of the E. Coli's epidemiological dynamics and the development of certain traits such as antibiotic resistance. To reach this goal, the study will take place in two successive phases : A first pilot phase will first be conducted with 50 healthy volunteers. During this pilot phase, a stool sample will be taken. The strains isolated during this pilot phase will be sequenced, making possible to characterize the strains present and the strains' possible changes between two stool samples. Succession rates will be estimated. The optimal sampling rate that maximizes accuracy in estimating succession rates will be identified and retained for the second phase. A second phase, a prospective cohort study will also be conducted in 200 healthy volunteers. During this second phase, healthy volunteers who participated in the first phase will be able to continue their participation and new volunteers will be selected. The healthy volunteers included in the prospective cohort study will be followed up with visits and stool samples which will be defined according to the results of the pilot phase.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05153824 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Escherichia Coli; Infection, Intestinal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05153824 currently recruiting?
Yes, NCT05153824 is actively recruiting participants. Contact the research team at xavier.duval@aphp.fr for enrollment information.
Where is the NCT05153824 trial being conducted?
This trial is being conducted at Paris, France, Paris, France.
Who is sponsoring the NCT05153824 clinical trial?
NCT05153824 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 200 participants.