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Gebruik van probiotica om reizigersdiarree te voorkomen (NL)


- candidate number2781
- NTR NumberNTR1077
- ISRCTNISRCTN76793515
- Date ISRCTN created26-feb-2007
- date ISRCTN requested26-feb-2007
- Date Registered NTR1-okt-2007
- Secondary IDsM 06/291 
- Public TitleGebruik van probiotica om reizigersdiarree te voorkomen (NL)
- Scientific TitleProbiotics in the prevention of traveller's diarrhoea
- ACRONYMN/A
- hypothesisUse of a well defined probiotic food supplement (Ecologic Travel) will reduce incidence of traveller's diarrhoea.
- Healt Condition(s) or Problem(s) studiedTraveller's diarrhoea
- Inclusion criteriaAdult travellers (18 years and above) to high risk areas (north Africa, Middle East, Asia, South and Central America) minimal 7 max 28 days travel.
- Exclusion criteriaUse of antibiotics or probiotics up to 2 weeks before travelling use of laxatives, acid blockers diarrhoea inhibitors gastrointestinal disease, pregnancy/lactation, frequent travel to high risk area without having had diarrhoea.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 2-jan-2007
- planned closingdate2-jan-2008
- Target number of participants800
- InterventionsUse of probiotic food supplement.
- Primary outcome50% reduction of incidence of traveller's diaarhoea.
- Secondary outcome
- Timepoints
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES K R Gadroen
- CONTACT for SCIENTIFIC QUERIES P A Kager
- Sponsor/Initiator Academic Medical Center, Travel Clinic, dept. Tropical Medicine
- Funding
(Source(s) of Monetary or Material Support)
Winclove Bio Industries B.V., Academic medidal Centre, Travel Clinic
- PublicationsN/A
- Brief summaryTraveller's diarrhoea occurs in 20 to 50 % of travellers to low or middle income countries. Several areas of the world are known for the high incidence of diarrhoea in visitors. Probiotics have been suggested as a save and effective method to prevent traveller's diarrhoea. So far studies are inconclusive, in part because various probiotics have been used, not always well defined. In this prospective, placebo controlled, double blinded study a well defined, multispecies probiotic product will be used.
- Main changes (audit trail)
- RECORD1-okt-2007 - 4-jun-2008


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