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Completed

NCT Number: NCT00979056

Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin

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

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Key information

Conditions

Diarrhoea Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institute of Tropical Medicine, University Hospital of Tübingen

Tübingen, 72074, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rifaximin

Drug

400 mg per day, oral use, maximum duration 28 days

Other names: Xifaxan, Normix, ATC code A07AA11, Chemical Abstracts Service (CAS) 80621814

lactose

Drug

Coated Tablet, Oral Use

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. Documentation of adverse effects and tolerance of prophylaxis with rifaximin.

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

  2. Evaluation of prevention of post infectious irritable bowel syndrome.

    Time frame: From the first day of the travel (travel period between 6 and 28 days) to 6 months after the subject's return to Germany

Sponsors and collaborators

Lead sponsor

Dr. Philipp Zanger, MD MSc DTM

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Sep 17, 2009
Registry last updated
Nov 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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