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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT02176005
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers
* Normal digestive transit, with usually one daily stool.
* Females participating in the study :
must be either of non-child bearing potential (surgically sterilized at least 3 months prior to inclusion, or postmenopausal or having a negative pregnancy test and be not breastfeeding at screening, and using abstinence or a double contraception method during the treatment period and for additional period of 2 weeks after the end of investigational treatment.
* Having given and signed the written study informed consent prior to undertaking any study-related procedure.
* Covered by the French Health Insurance system.
Exclusion Criteria:
* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological, neurological, bone and joint, muscular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness.
* Contra-indications to fluoroquinolones, or risk factors for adverse events associated to fluoroquinolones.
* Subjects with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency should be excluded.
* Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should be excluded.
* Contra-indications to DAV132, risk of gastrointestinal obstruction, perforation or haemorrhage, recent digestive tract surgery.
* Fecal colonisation by Clostridium difficile.
* Recent history of hospitalisation (within 3 months prior to inclusion).
* Any antibiotic administration within 3 months before inclusion.
* Any vaccination within the last 28 days.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02176005
Study Brief:
Protocol Section:
NCT02176005