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.

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. - ROBIN

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45590

Enrollment

Registered

2017-03-16

Start date

2017-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect of probiotics on small intestinal microbiota Small intestinal microbiota

Interventions

Subjects receive dietary guidelines for 37 days (Study day -14 until Study day 23). IntelliCap® CR capsule sampling will be performed at study day 7. At study days 14-20, all subjects will consume 1

IntelliCap

Microbiota

Probiotics

Small Intestine

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Microbiota composition in the small intestine (Next Generation Sequencing).	—

Secondary

Measure	Time frame
Microbiota composition in feces (Next Generation Sequencing), stool frequency, stool consistency (Bristol Stool Scale), timing of daily behavior, gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale)	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)