gastroenteritis traveler's diarrhea
Conditions
Interventions
The PRETEC study is a dietary intervention with oral probiotics. Twice daily,
preferably at breakfast and dinner, subjects consume 10E9 colony-forming units
of Lactobacillus acidophilus NCFM. The pr
Sponsors
Danisco Finland
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Healthy male subjects, aged 20-55 yrs, living in the Ede/Wageningen neighbourhood - Informed Consent
Exclusion criteria
Exclusion criteria: - Measurable serum antibody titer against enterotoxigenic E. coli - Carrier of streptomycin-resistant E. coli (in faeces) - Presence or former gastrointestinal diseases - Lactose intolerance - Use of antibiotics, norit, laxatives (up till 6 months prior to inclusion), cholestyramine, acid burn inhibitors or immune suppressors (up till 3 months prior to inclusion), and pre- and probiotics (up till 1 month prior to inclusion) - Vegetarians - Heavy alcohol use - Drug use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Faecal ETEC excretion with time as marker of the colonization resistance • Total daily faecal output as marker of diarrhea | — |
Secondary
| Measure | Time frame |
|---|---|
| • Bowel habits • Frequency and severity of gastrointestinal symptoms • Diarrhea severity (as measured by faecal dry weight excretion and % faecal dry weight) • Opportunistic pathogens in faeces • Calprotectin • Specific serum antibody response to CFA-II • Total faecal sIgA | — |
Countries
Netherlands
Outcome results
None listed