The effect of daily consumption of a probiotic drink containing Lactobacillus casei Shirota on the small intestinal microbiota in healthy male subjects as measured by the Intellicap sampling capsule system.<br> - ROBI

The Yakult Honsha European Research Center for Microbiology, ESV (YHER)0 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•2. Age 18-30yrs
•3. BMI between 18,5-25 kg/m2
•4. Healthy as assessed by the NIZO lifestyle and health questionnaire (*Verklaring leefgewoonten en gezondheid*).
•5. Non-smoking
•6. Regular bowel movement (defecation on average once a day, at least 4 times/week).
•7. Signed informed consent

•1. Alcohol consumption > 15 units/week and > 3/day.
•2. Allergic to dairy products (milk allergy or lactose intolerance).
•3. Carrying a pacemaker or any other (implanted) medical electronic device.
•4. Drug abuse.
•5. Having diarrhea within two (2) months prior to the study start.
•6. Heavy exercise or sports training > 10 hours/week.
•7. History or presence of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject*s ability to participate in the study.
•8. Mental status that is incompatible with the proper conduct of the study.
•9. Participation in any scientific study with oral, intravenous or inhalatory administration of any substances during two (2) months before study start.
•10. Presence of swallowing disorder or problems with gastro-intestinal transit.
•11. Reported special diets such as vegetarian, vegan, or macrobiotic.
•12. Scheduled for an MRI scan during the study period.
•13. Unstable body weight (weight gain or loss >5kg in the past three (3) months).
•14. Use of antibiotics during the six (6) months prior to study start.
•15. Use of any prescribed or non-prescribed medication (other than paracetamol) during the three (3) weeks prior to study start.
•16. Use of laxatives and probiotic, prebiotic and fiber supplements during the two (2) months prior to study start.

发起方

The Yakult Honsha European Research Center for Microbiology, ESV (YHER)