| - candidate number | 2441 |
| - NTR Number | NTR905 |
| - ISRCTN | ISRCTN76793515 |
| - Date ISRCTN created | 26-feb-2007 |
| - date ISRCTN requested | 21-feb-2007 |
| - Date Registered NTR | 31-jan-2007 |
| - Secondary IDs | N/A |
| - Public Title | Probiotics in the prevention of traveller's diarrhoea. |
| - Scientific Title | Probiotics in the prevention of traveller's diarrhoea. |
| - ACRONYM | N/A |
| - hypothesis | A relative reduction of 50% in the occurence of traveller's diarrhoea. |
| - Healt Condition(s) or Problem(s) studied | Prebiotics, Traveller's diarrhoea , Lactobacillus, Bifidobacterium |
| - Inclusion criteria | 1. Both male and female adults (+18); 2. Travelling to high risk area's for TD (Midle east, Asia, South and Central America, North Africa); 3. Duration of travelling: min. 7 days, max. 28 days; 4. People who experienced TD before; 5. All new travellers to high risk area's |
| - Exclusion criteria | 1. Use of antibiotics until two weeks before leaving; 2. Use of laxatives, acid blockers and diarrhoea inhibitors; 3. Persons who already have complaints about their stomach and/or intestines; 4. IBS/IBD and stoma patients; 5. Pregnant or breastfeeding women; 6. Patients with a serious disturbed or fragile/weak immune system (according to LCR criteria); 7. Use of probiotics two weeks before start of journey; 8. Frequent traveller's to high risk area's who never had TD complaints. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 12-jan-2007 |
| - planned closingdate | |
| - Target number of participants | 800 |
| - Interventions | Ecologic Travel ®, a multispecies probiotic product versus a placebo. Intervention consists of one sachet probiots in powder form containing the following strains: Bifidobacterium bifidum, Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus salivarius and Lactococcus lactis.(Minimal number of cells: 1*109cfu/g). |
| - Primary outcome | 1. Consistency of stools according to Bristol scale; 2. Frequency of stools. |
| - Secondary outcome | Duration of traveller's diarrhoea |
| - Timepoints | |
| - Trial web site | http://www.winclove.nl/nieuws12.htm |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | E. Dijk, van |
| - CONTACT for SCIENTIFIC QUERIES | E. Dijk, van |
| - Sponsor/Initiator | Academic Medical Center (AMC), Center for Tropics |
| - Funding (Source(s) of Monetary or Material Support) | Winclove Bio Industries B.V., Academic Medical Center (AMC), Center for Tropics |
| - Publications | N/A |
| - Brief summary | Traveller's diarrhoea (TD) is a common health complaint affecting healthy travellers. With an incidence rate of 20-50% it has been estimated that the illness affect at least 11 million people annually. Because of the widely varying causes of TD, the chances developing an effective vaccine for prophylaxis are limited. Antibiotics are effective prophylaxis but are not recommended for widespread use and thus there is a need for cost-effective alternative treatments. Probiotics, non-pathogenic micro-organisms which exert a positive health benefit to their host, have been suggested as a safe and effective method to prevent TD. In this study, Ecologic Travel ®, a multispecies probiotic product or a placebo is given to a group of 800 healthy, adult travellers to high risk areas for TD. By collecting Bristol scale scores such as type (consistency) of stools and frequency of stools, the occurence of TD is established. TD is defined as the passage of 3 or more unformed stools over 24 h. |
| - Main changes (audit trail) | |
| - RECORD | 31-jan-2007 - 26-feb-2007 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl