This is a pilot study investigating how a novel probiotic supplement (BEO001), with and without a dietary fiber (beta-glucan), affects the lining of the small intestine in healthy people. The main goal is to see if a single dose of the probiotic changes gene activity (transcriptomics) and sugar molecule patterns (glycomics) in the gut. Eight participants will take three different treatments (placebo, probiotic alone, probiotic with fiber) in a random order, with at least 10 days between each. A gastroscopy to collect small intestinal tissue samples (biopsies) is performed the morning after each treatment. Blood and breath samples are also collected at these visits to explore effects on metabolism and inflammation. To understand how different sampling methods compare, participants collect stool samples and simple rectal swabs at home before any treatment. Researchers analyze the sugar molecules and bacteria in these samples, then compare them to each other and to the gut tissue samples collected after treatment. This helps determine if easier-to-collect samples can provide similar information to gut biopsies. The study also aims to combine all data (including genetics and diet) to identify key targets for future research and to attempt to grow 'mini-gut' organoids from the biopsies. The results will help design larger future studies in people with high uric acid levels.
Signed informed consent.
Age 18-60 years.
BMI 18.5 - 29.9 kg/m².
Willing to avoid probiotics, fermented foods, and maintain stable diet/lifestyle for the study duration.
Chronic GI, inflammatory, metabolic (including renal), or significant psychiatric disease.
Acute infection/allergy within 2 weeks.
Regular use of NSAIDs, antibiotics, steroids, immunomodulators.
Alcohol >9 units/week.
Crossover
BEO001 Probiotic
Dietary supplementA mixture of two probiotic strains. Total dose ≥5x10\^10 CFU of each strain per intervention day. Administered as a powder mixed with water, consumed in several portions.
BEO001 Probiotic + Beta-Glucan
Dietary supplementThe BEO001 probiotic (as above) co-administered with 3g of a food-grade beta-glucan fiber. Both are powders mixed with water.
Placebo
Dietary supplementPowder without the active probiotic strains or beta-glucan
Change in small intestinal transcriptomic profile after BEO001 intake
Gene expression profile (analyzed by RNA sequencing) in duodenal mucosal biopsies collected the morning after a single evening dose of BEO001 probiotic. Comparison is made between intervention visits (BEO001 vs. placebo).
Change in small intestinal transcriptomic profile after BEO001+beta-glucan intake.
Gene expression profile in duodenal biopsies after a single evening dose of BEO001 with beta-glucan. Comparison is made between intervention visits (BEO001+beta-glucan vs. placebo).
Change in small intestinal glycomic profile after BEO001 intake
N- and O-glycan profiles (analyzed by LC-MS) in duodenal biopsies after a single evening dose of BEO001. Comparison is made between intervention visits (BEO001 vs. placebo).
Change in small intestinal glycomic profile after BEO001+beta-glucan intake.
N- and O-glycan profiles in duodenal biopsies after a single evening dose of BEO001 with beta-glucan. Comparison is made between intervention visits (BEO001 +beta-glucan vs. placebo).
Change in small intestinal mucosal microbiome composition and function.
Microbial community profile and functional gene content (shotgun metagenomics) in duodenal biopsies. Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
Change in blood urate concentrations
Levels of urate in blood . Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
Change in blood creatinine
Levels of creatinine in blood . Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
Change in blood metabolites and enzymes related to urate and inflammation.
Concentrations of targeted metabolites and enzymes (including short-chain fatty acids) in blood. Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
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Örebro University, Sweden
Lead sponsor
University of Copenhagen
Collaborator
European Innovation Council
Collaborator
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