Primary Exploratory Objective:* To explore the effect of Lactobacillus casei strain Shirota (LcS) on small intestinal microbiota profiles.Secondary Exploratory Objectives:* To explore the differences between the effect of LcS on small intestinal and…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Effect of probiotics on small intestinal microbiota
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Microbiota composition in the small intestine (Next Generation Sequencing).
Secondary outcome
Microbiota composition in feces (Next Generation Sequencing), stool frequency,
stool consistency (Bristol Stool Scale), timing of daily behavior,
gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale)
Background summary
Currently, obtaining samples directly from the small bowel is difficult due to
the highly invasive intubation methods used. Research on the effect of dietary
probiotics on the gut microbiota is therefore largely dependent on measurement
of the microbial composition in fecal samples. At best, the measurement in
fecal samples reflects microbial composition of the large intestine.
The microbial composition in the small intestine differs substantially from the
composition in feces. In addition, many physiological processes that are
modulated by dietary probiotics, such as immunoregulation, mainly occur in the
small intestine.
Therefore, it is vital to study the effects of dietary probiotics on the small
intestinal microbiota, as well. Successful sampling of the small intestine has
been demonstrated in animals and humans, using the IntelliCap® CR system.
This study is explorative in nature. The main aim of the current study is to
explore and compare the small intestinal microbiota composition in healthy
subjects before and after consumption of a probiotic drink containing
Lactobacillus casei strain Shirota (LcS) (Yakult®).
Study objective
Primary Exploratory Objective:
* To explore the effect of Lactobacillus casei strain Shirota (LcS) on small
intestinal microbiota profiles.
Secondary Exploratory Objectives:
* To explore the differences between the effect of LcS on small intestinal and
fecal microbiota profiles.
* To explore the recovery rate of LcS in the small intestine and feces.
* To investigate the effect of LcS on reported stool frequency, stool
consistency (Bristol Stool Scale), and gastrointestinal symptoms
(Gastrointestinal Symptom Rating Scale).
Tertiary Exploratory Objectives:
* To assess feasibility of measuring potential biomarkers in the small
intestinal sample collected by the IntelliCap® CR capsule: metabolomes
(UHPLC-HRMS), organic acids (HPLC), fatty acids (Colorimetric/Fluorometric
assay), calcium (Colorimetric assay), defensin (ELISA), and LcS count (PCR) in
small intestinal and fecal samples.
Study design
The study is a dietary intervention study with a repeated measures design,
comparing the upper GI microbiota composition in healthy male subjects before
and after consumption of a probiotic drink containing LcS.
Intervention
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 probiotic drink containing LcS
(Yakult®) daily. A second IntelliCap® CR capsule sampling will be performed at
day 21. After IntelliCap® CR capsule sampling, subjects have to collect all
stool samples until retrieval of the IntelliCap® CR capsule device.
Subjects have to record stool frequency, stool consistency (Bristol Stool
Scale) and timing of daily behavior (wake up-, bed-, meal-, defecation time)
and compliance to study guidelines on study day 1-23. On study day 7 and 21,
subjects have to record gastrointestinal symptoms (Gastrointestinal Symptom
Rating Scale).
Study burden and risks
The burden of the subjects that participate in this study consist of investing
15 hours in total for screening, dietary guidelines, sampling days with
IntelliCap CR capsule intake, and fecal sample collection. Participants will
not directly benefit from the study. There are minor risks for the participants
during the study. The CE certified IntelliCap® CR system, used as minimally
invasive sampling device and validated in humans, is safe and well tolerated.
If the IntelliCap® CR capsule is not recovered from the feces within 7 days
after administration, an abdominal X-ray will be performed to check if the
IntelliCap® CR capsule is still within the body. For the quencher, present in
the IntelliCap® CR capsule, thorough safety reports have been written, showing
that the doses used in the capsule are safe for human application.
Based on these considerations, to our opinion, the risks for participation in
this study are negligible, and we have made every effort to minimize potential
risks. Therefore, we feel that the remaining risks are acceptable and do not
outweigh the scientific relevance of this study.
Technologiepark 4
Gent-Zwijnaarde 9052
BE
Technologiepark 4
Gent-Zwijnaarde 9052
BE
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59320.081.16 |