Diarrhoea
Conditions
Keywords
Traveller's diarrhoea, Prevention
Brief summary
The aim of the study is to investigate the efficacy of the prophylactic treatment with rifaximin to prevent travellers diarrhoea.
Interventions
DRUGRifaximin
400 mg per day, oral use, maximum duration 28 days
DRUGLactose
Coated Tablet, Oral Use
Sponsors
Dr. Philipp Zanger, MD MSc DTM
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of the prevention of travellers diarrhea with rifaximin by measurement of frequency and consistence of the stool. Diarrhea will be defined as passage of >2 unformed stools/24 hr plus one or more signs or symptoms of enteric infection. | From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany |
Secondary
| Measure | Time frame |
|---|---|
| Documentation of adverse effects and tolerance of prophylaxis with rifaximin. | From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany |
| Evaluation of prevention of post infectious irritable bowel syndrome. | From the first day of the travel (travel period between 6 and 28 days) to 6 months after the subject's return to Germany |
Countries
Germany
Outcome results
None listed