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| Name | Class |
|---|---|
| NIZO Food Research | OTHER |
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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. The main aim of the current study is to explore and compare the small intestinal microbiota profiles in healthy subjects before and after consumption of a probiotic drink containing Lactobacillus casei strain Shirota (LcS) (Yakult®).
The study is a dietary intervention study with a repeated measures design, comparing the upper gastrointestinal microbiota profiles in healthy male subjects before and after consumption of a probiotic drink containing LcS.
This study is explorative in nature. This pilot-study is used to explore trends in microbiota profile shifts in the small intestine. In addition, the investigators would like to explore whether these microbial shifts are similar to those observed in fecal samples. Information derived from this pilot-study can be used to design future intervention studies focusing on either the effect of probiotics on microbial shifts in the small or large intestine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary Supplement: Lactobacillus casei strain Shirota (LcS) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus casei strain Shirota (LcS) | Dietary Supplement | A fermented milk containing LcS, 65 ml for oral administration, 1 bottle per day for 7 days. One bottle of the drink contains: 42.9 kcal/182 kJ; less than 0.1 g of fat; 9.6 g of carbohydrate; 0.01 g of sodium; 0.9 g of protein; and at least 6.5 x 10^9 colony-forming units of LcS. |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiota composition in the small intestine | Relative abundance of microbiota species (% of total) in the small intestine | 7 days after consuming a probiotic drink containing Lactobacillus casei strain Shirota (LcS) |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiota composition in feces | Relative abundance of microbiota species (% of total ) in feces | 7 days after consuming a probiotic drink containing LcS |
| LcS recovery | LcS recovery in the small intestine and feces |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers | Feasibility assessment of measuring potential biomarkers in the small intestine and feces | 7 days after consuming a probiotic drink containing LcS |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandra ten Bruggencate, PhD | Contact | +31318659504 | sandra.tenbruggencate@nizo.com | |
| Els Van Hoffen, PhD | Contact | +31318659560 | els.vanhoffen@nizo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIZO Food Research | Recruiting | Ede, Utrecht, | 6718 ZB | Netherlands |
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The study is a dietary intervention study with a repeated measures design, comparing the upper gastrointestinal microbiota profiles in healthy male subjects before and after consumption of a probiotic drink containing Lactobacillus casei strain Shirota.
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| 7 days after consuming a probiotic drink containing LcS |
| Stool habits | Effect of LcS on stool frequency, stool consistency and gastrointestinal symptoms | 7 days after consuming a probiotic drink containing LcS |