Actively Recruiting
Study of the Ecological and Evolutionary Dynamics of Escherichia Coli in the Digestive Commensal Flora
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2023-04-10
200
Participants Needed
2
Research Sites
339 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of the Ecological and Evolutionary Dynamics of Escherichia Coli in the Digestive Commensal Flora
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteer of any sex between 18 and 65 years old
- Considered healthy after a thorough general examination
- Normal bowel movements with usually one formed stool per day
- Body mass index (BMI) between 18.5 and 35 kg/m²
You will not qualify if you...
- Living in an institution
- Known immunosuppression including HIV, immunosuppressive therapy, chemotherapy, or long-term corticosteroids within the last 6 months
- Chronic gastrointestinal diseases such as chronic hemorrhagic recto-colitis or Crohn's disease
- Any digestive surgery except appendectomy or polyp removal
- History of bloodstream infection (bacteremia)
- Under legal protection such as guardianship or curatorship
- Pregnant or lactating women
- Deprived of liberty under judicial duress
- Not affiliated with a social security scheme
- Receiving State Medical Aid
- Lack of signed consent before entering the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Bichat Claude Bernard Hospital
Paris, France, 75018
Actively Recruiting
2
Bichat Hospital, Clinical Investigation Center
Paris, France, 75018
Actively Recruiting
Research Team
X
Xavier M DUVAL, MD, PhD
CONTACT
F
François BLANQUART, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here