Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin

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

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

Conditions
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Diarrhoea

Intervention / Treatment
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* Drug: Rifaximin
* Drug: Lactose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rifaximin<br> | Drug: Rifaximin<br>* 400 mg per day, oral use, maximum duration 28 days<br>* Other names: Chemical Abstracts Service (CAS) 80621814;|
| Placebo Comparator: Lactose<br> | Drug: Lactose<br>* Coated Tablet, Oral Use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traveller's diarrhoea, Prevention