Microbiota Composition in the Human Small Intestine Clinical Trial
Official title:
MICRO-study: The IntelliCap® System as a Gastrointestinal Fluid Sampling Tool
This study will explore whether the IntelliCap® system can be used to study the human microbiota composition in the small intestine. The IntelliCap® system is an oral drug delivery and patient monitoring system consisting of a capsule-shaped device and ancillary equipment. The IntelliCap® capsule is also able aspirate fluid from its environment. Here, we explore whether the capsule is able to take a fluid sample from the lumen of the gastrointestinal tract for microbiota analysis. To study this, a controlled dietary intervention that is expected to induce a temporary change in microbiota composition will be performed in healthy volunteers. Microbiota composition of samples collected from the small intestine using the IntelliCap® system will be compared to fecal samples from the same individuals collected at the same time point.
The gut microbiota is involved in regulation of host metabolic and immune pathways, and is
an important target for dietary interventions. Studies on human microbiota are mainly based
on the analysis of fecal samples. The microbiota in the small intestine is at least equally
relevant for health as in the large intestine, but the regional composition differs largely.
Small intestinal sampling requires invasive procedures. Recently, an electronic medical
device, the IntelliCap® system, was developed for the site-specific delivery of drugs in the
gastrointestinal tract and patient monitoring. This capsule has been adapted to be used to
aspirate liquid from its environment. The IntelliCap® system may offer a minimally-invasive
tool for sampling of small intestinal fluid in humans for microbiota analysis.
Objective: To evaluate the IntelliCap® system as a tool to study changes in small intestinal
microbiota composition in humans in vivo and its safety and tolerability.
Study design: A randomized cross-over controlled feeding trial in humans will be performed
in 10 healthy male volunteers (age 18-30 yr). Two diets are used: a three-day high-protein
versus a high-carbohydrate diet, each preceded by a washout diet. These diets target
microbiota with fundamentally different fermentation requirements. The IntelliCap® capsule
is administered after both intervention periods to collect a fluid sample from the distal
small bowel. In parallel, fecal samples are collected. Microbiota composition is analyzed by
sequencing using Illumina technology followed by dedicated bioinformatic analysis. Blood
samples will be collected and stored to measure metabolic parameters and markers of satiety
that can potentially be correlated to the microbiota data.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science