Healthy Clinical Trial
Official title:
The Effect of Daily Consumption of a Probiotic Drink Containing Lactobacillus Casei Strain Shirota on the Small Intestinal Microbiota in Healthy Male Subjects as Measured by the IntelliCap Sampling Capsule System.
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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