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Clinical Trial 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. 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®).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03114839
Study type Interventional
Source Yakult Honsha European Research Center, ESV
Contact Sandra ten Bruggencate, PhD
Phone +31318659504
Status Recruiting
Phase N/A
Start date September 4, 2017
Completion date February 28, 2018

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