Clinical Trial: Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Prospective, Randomised, Placebo Controlled, Double Blind Monocenter Trial for the Prophylactic Treatment of Diarrhoea With Rifaximin for Travellers to South- and Southeas
Brief Summary: The aim of the study is to investigate the efficacy of the prophylactic treatment with rifaximin to prevent travellers diarrhoea.
Detailed Summary:
Sponsor: Dr. Philipp Zanger, MD MSc DTM
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
- 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 ]
Original Secondary Outcome: Same as current
Information By: University Hospital Tuebingen
Dates:
Date Received: September 16, 2009
Date Started: October 2009
Date Completion:
Last Updated: November 7, 2013
Last Verified: November 2013
