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:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT00979056
Eligibility Criteria:
Inclusion Criteria:
* Adults ≥ 18 and \< 65 years
* Good general condition (according to history and clinical examination)
* Written informed consent
* No pregnancy
* No breast feeding
* Efficacious contraception (e.g. oral, double-barrier) during the study and 4 weeks after termination of the study
* No participation in other clinical trials 4 weeks before, during participation, and 4 weeks after participation in this study
* Planned travel period between 6 and 28 days
* Planned travel to South- and Southeast Asia
* Planned time to arrival in South- or Southeast Asia ≤ 24 hours
Exclusion Criteria:
* Pregnancy
* Breast feeding
* Age \< 18 and ≥ 65 years
* No written informed consent
* Chronic gastrointestinal disease and/ or immune insufficiency
* Low general condition (according to history and clinical examination)
* Regular medication with gastrointestinal side-effects and/or immunosuppressive medication
* Participation in other clinical trials 4 weeks before, during and 4 weeks after termination of the study
* No efficacious contraception
* Planned travel period \< 6 and \> 28 days
* Planned travel outside South- and Southeast Asia
* Vaccination against cholera using DUKORAL within 12 months prior to inclusion
* Planned time to arrival in South- or Southeast Asia \> 24 hours
* Known hypersensitivity against rifaximin or rifamycin-derivatives in general
* Known lactose intolerance
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT00979056
Study Brief:
Protocol Section:
NCT00979056