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>
- Conditions
- Effect of probiotics on small intestinal microbiotaSmall intestinal microbiota
- Registration Number
- NL-OMON45590
- Lead Sponsor
- The Yakult Honsha European Research Center for Microbiology, ESV (YHER)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 6
1. Male
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Microbiota composition in the small intestine (Next Generation Sequencing). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Microbiota composition in feces (Next Generation Sequencing), stool frequency,<br /><br>stool consistency (Bristol Stool Scale), timing of daily behavior,<br /><br>gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale)</p><br>