Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin

Prospective, Randomised, Placebo Controlled, Double Blind Monocenter Trial for the Prophylactic Treatment of Diarrhoea With Rifaximin for Travellers to South- and Southeast-Asia

The aim of the study is to investigate the efficacy of the prophylactic treatment with rifaximin to prevent travellers diarrhoea.

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