Populatie van bacterien in de darm en algemene gezondheid en "innate immunity" traveler's diarrhoea
Conditions
Interventions
One group receives twice daily two sachets containing 450 billion live
freeze-dried lactic acid bacteria per sachet and the other group receives twice
daily a two placebo sachets. On day 21 all volu
Sponsors
TNO
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy as assessed by the - health and lifestyle questionnaire, (P9067 F02; in Dutch) - physical examination - results of the pre-study laboratory tests 2. Males, Age 21 - 40 years at Day 01 of the study 3 Body Mass Index (BMI) >20 and
Exclusion criteria
Exclusion criteria: Subjects with one or more of the following characteristics will be excluded from participation: 1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study 2. Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances 3. Having a history of medical or surgical events that may significantly affect the study outcome, including gastrointestinal illness or surgical operations, 4. Use of antibiotics, immunosuppressive drugs, antacids, laxatives or antidiarrheal drugs in the last 3 months before the study 5. Alcohol consumption > 28 units/week for males . 6. Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening 7. Reported slimming or medically prescribed diet 8. Reported vegan, vegetarian or macrobiotic 9. Working as a food handler, in child care or as a healthcare worker with direct patient contact 10. Not willing to give up blood donation during the study. 11. Personnel of TNO Quality of Life, their partner and their first and second degree relatives 12. Not having a general practitioner 13. Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the percent change in faecal dry weight and total faecal output between the probiotics group and the placebo group | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition, intestinal permeability, inflammation and other clinical symptoms will be evaluated. | — |
Countries
Netherlands
Outcome results
None listed