MICRO-study: The IntelliCap® System as a Gastrointestinal Fluid Sampling Tool
Condition: Microbiota Composition in the Human Small Intestine
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): diet; IntelliCap® system
Intervention type(s): Other; Device
Intervention description(s): A controlled diet will be provided to participants which consists of either high protein/low carbohydrate, or of low protein/high carbohydrate.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: microbiota; small intestine; diet; feces