Study of the Ecological and Evolutionary Dynamics of Escherichia Coli in the Digestive Commensal Flora

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
France
Bichat Claude Bernard Hospital
RECRUITING
Paris
Bichat Hospital, Clinical Investigation Center
RECRUITING
Paris
Contact Information
Primary
Xavier M DUVAL, MD, PhD
xavier.duval@aphp.fr
+33 (0)1 40 25 71 48
Backup
François BLANQUART, PhD
francois.blanquart@college-de-france.fr
+33 (0)1 44 27 13 79
Time Frame
Start Date: 2021-03-02
Estimated Completion Date: 2027-09-02
Participants
Target number of participants: 200
Treatments
Healthy volunteers
Healthy volunteers
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov