Gastroenteritis Traveler's diarrhea
Conditions
Interventions
During the entire study, subjects will be instructed to maintain their habitual
diet, except for their dairy intake. Dairy has a high calcium content and
contributes significantly to total daily cal
Sponsors
PanTheryx, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 55 years. 2. BMI *18 and *27 kg/m2. 3. Healthy as assessed by the NIZO food research medical questionnaire.
Exclusion criteria
Exclusion criteria: 1. Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus infection (HIV). 2. Disease of the GI tract, liver, bile bladder, kidney, thyroid gland (self-reported). 3. Diarrheagenic E. coli strain (as used in the study) detected in fecal sample at screening. 4. Evidence of current excessive alcohol consumption or non-therapeutic drug (ab)use). 5. High titer serum antibodies against CFA-II diarrheagenic E. coli strain (as used in the study) at screening. 6. History of microbiologically confirmed ETEC or cholera infection in last 3 years. 7. Known allergy to the following antibiotics: ciprofloxacin, trimethoprim-sulfamethoxazole, and penicillins. 8. Known allergy to soy, milk- and/or egg. 9. Mental status that is incompatible with the proper conduct of the study. 10. Occupation involving handling of ETEC or Vibrio cholerae currently, or in the past 3 years. 11. Reported average stool frequency of 3 per day. 12. 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 dosing, OR planned travel to endemic countries during the length of the study. 13. Use of antibiotics, norit, laxatives (up till 6 months prior to inclusion), cholesterol lowering agents, antacids, proton pump inhibitors and immune suppressive agents (up till 3 months prior to inclusion) 14. Vaccination for or ingestion of ETEC, cholera, or E coli heat labile toxin within 3 years prior to inclusion. 15. Vegans.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are Stool consistency (Bristol Stool Scale reported by the subjects in the online diary, and Percentage of fecal wet weight (% determined by freeze-drying). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are: Stool frequency (Stools per day reported by the subjects in the online diary), Total fecal wet weight (fecal weight in g/day), and the incidence and severity of Gastro-intestinal symptoms (Gastro-intestinal Symptom Rating Scale reported by the subjects in the online diary). | — |
Countries
Netherlands
Outcome results
None listed