Ileostomy cohort study with two probiotics (INSIDE Project)

INSIDE project

The aim of the study is to determine the small intestinal microbiota response in humans to probiotic supplement interventions for two consecutive weeks, and to relate this to intestinal barrier function and immune and metabolic responses in blood, as functional outcome parameters of host physiology.

A small cohort of ileostoma subjects has been recruited to participate in a three-arm intervention trial according to a double blind, cross-over, placebo-controlled design. Two probiotics products and a placebo were administered in random order to each volunteer for two weeks with 2 week wash-out periods in between interventions. The volunteers will participate in this study for approx. 100 days and will, in addition to the three interventions, not consume fermented products. The following samples will be obtained and analyses will be performed:

• Small size samples of ileostomy effluent (across the whole period) --> Microbial composition via 16S analysis
• Urine samples --> Metabolome analysis
• Blood samples, plasma preparation --> Metabolome analysis, biomarker identification
• Blood samples, PBMCs isolation --> RNA extraction and transcriptome analysis
• Blood samples, ex vivo stimulation --> Immunoresponsiviness 
• Large effluent samples --> RNA extraction and analyte profiling
• Small size ileostomy samples --> Small chain fatty acid composition
• Urine samples --> Sugar permeability test