Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT02659033
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 65 years
* Volunteer regarded as healthy after detailed examination
* Subject whose entourage (person living under the same roof) does not present any chronic disease throughout the course and did not receive antibiotics within 15 days.
* Effective contraception for women in reproductive age and negative pregnancy test before inclusion
* Normal intestinal passage (one stool per day)
* Negative urinalysis for toxic substances
* Normal blood test (including blood and platelets counts, prothrombin, ionograms, Liver function tests)
* Negative HIV and HCV (hepatitis C virus) test, no HBV (hepatitis B virus)chronic infection
* Normal weight (BMI comprised between 19 and 29 kg/m²)
* Freely obtained consent
* Health insurance beneficiary
Exclusion Criteria:
* Antibiotic therapy in the previous 6 months
* Hospitalisation in the previous 12 months;
* Active infection
* Ongoing treatment
* Any chronic disease
* Allergy to one of the study drugs
* Any contraindications to β-lactam therapy in particular to penicillins or cephalosporins
* Pregnancy or no effective contraception, suckling women
* Subject, as determined by the investigating physician, could not observing during the study, or unable to communicate because of language or mental disorders barrier;
* Subject participating simultaneously in another biomedical research
* Subject can not be contacted in case of emergency;
* Subject about legally protected under tutorship or curators;
* Subject deprived of freedom under judicial or administrative constraints
Secondary exclusion criteria
* No pre-treatment stool sample obtained
* More than one stool sample missing from D1 to D7
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02659033
Study Brief:
Protocol Section:
NCT02659033