CompletedPhase 3

Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin

Germany258 participantsStarted 2009-10

Plain-language summary

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

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany

Trial details

NCT IDNCT00979056

SponsorDr. Philipp Zanger, MD MSc DTM

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-03

View on ClinicalTrials.gov More Diarrhoea trials