gastroenteritis traveler's diarrhea
Conditions
Interventions
The PROTETEC study is a dietary intervention with oral probiotics. Twice daily,
at breakfast and dinner, subjects consume 5 x 10E9 colony forming units
Protecflor. The probiotics are supplied as cap
Sponsors
Lallemand Human Nutrition
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 - Availability of internet connection - Willingness to replace habitual dairy product intake with the supplied low-calcium soy products - Willingness to abstain from products with high amounts of prebiotic fibers and from products with probiotics (except for the supplied one) starting 1 month prior to study start - Willingness to give up blood donation from 1 month before the start of the experiment and during the entire experimental period.
Exclusion criteria
Exclusion criteria: - Current or previous underlying disease of the GI tract - Allergy to milk products or lactose intolerance (self-reported), since the capsules may contain milk traces from culture media - Allergy to soy products (self-reported) - Use of antibiotics, norit, laxatives (up till 6 months prior to inclusion), cholestyramine, acid burn inhibitors or immune suppressive (up till 3 months prior to inclusion), and pre- and probiotics (up till 1 month prior to inclusion). - High titer serum antibodies against ETEC (10 ml blood sample collected at screening). - Vegetarians - Vegans - Heavy alcohol use (>4 consumptions/day or >20/week) - 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) - Specific serum antibody response to CFA-II Tertiary study outcomes (performance will depend on results primary and secundary markers) - Opportunistic pathogens in faeces - Calprotectin - Total faecal sIgA | — |
Countries
Netherlands
Outcome results
None listed