Gastroenteritis Travelers diarrhea
Conditions
Interventions
During 4 weeks, subjects will receive either control product (whey hydrolysate,
23 gr/serving, twice daily), high dose minimally processed milk product (23
g/serving, twice daily), or low dose minim
Sponsors
FrieslandCampina Nederland BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male 2. Age between 18 and 55 years. 3. BMI *18.5 and *30.0 kg/m2. 4. Healthy as assessed by the NIZO food research medical questionnaire.
Exclusion criteria
Exclusion criteria: 1. Acute gastroenteritis in the 2 months prior to inclusion. 2. Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus infection (HIV). 3. Disease of the GI tract, liver, bile bladder, kidney, thyroid gland (self-reported), except for appendicitis. 4. History of microbiologically confirmed ETEC or cholera infection within 3 years prior to inclusion. 5. Symptoms consistent with Travelers' Diarrhea concurrent with travel to countries where ETEC infection is endemic (most of the developing world) within 3 years prior to inclusion, OR planned travel to endemic countries during the length of the study. 6. Vaccination for, or ingestion of cholera within 3 years prior to inclusion, including studies at NIZO. 7. Occupation involving handling of ETEC or Vibrio cholerae currently, or within 3 years prior to inclusion. 8. Vaccination for, or ingestion of ETEC or E coli heat labile toxin, including E. coli challenge studies at NIZO. 9. Evidence of current excessive alcohol consumption (>4 consumptions/day or >20 consumptions/week) or drug (ab)use, and not willing/able to stop this during the study. 10. Known allergy to the following antibiotics: ciprofloxacin, trimethoprim, sulfamethoxazole, and penicillins. 11. Reported average stool frequency of >3 per day or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters: * Stool frequency at day 16 (2 days after infection) compared to day 15 (1 day after infection): number of stools per day, recorded in online diary * Diarrhea complaints at day 16 compared to day 15, as measured by GSRS questionnaire (Gastro-intestinal Symptom Rating Scale, domain diarrhea), recorded in online diary | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameter: * Stool consistency at day 16 compared to day 15, as measured by Bristol Stool Score (BSS, scale 1-7, recorded in online diary) Exploratory parameters, in case of positive outcome of main or secondary study parameters: * Overall kinetics of the clinical symptoms (GSRS, stool frequency, BSS) on the four days after infection * Percentage fecal wet weight: day 16 compared to day 15, and overall kinetics on the four days after infection, as compared to baseline * Exploration of biomarkers in blood or feces samples before and after run-in, or fecal samples before and after infection, that may predict or explain the effect of a minimally processed milk product on the clinical symptoms. Optional biomarkers: immune (e.g. E. coli specific antibody levels), inflammation (e.g. calprotectin, CRP, gut barrier markers), microbiota-related (microbiota composition or metabolites) or cellular biomarkers (e.g. neutrophil function, phagocytosis, monocyte and/or DC activation, transcriptomics) Explorative parameter to study feasibility of VOC as non-invasive biomarker: * VOC in exhaled breath: changes in composition between day 15 (1 day after infection) and day 13 (pre-infection). | — |
Countries
Netherlands
Outcome results
None listed